Trial Outcomes & Findings for Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC) (NCT NCT01862315)
NCT ID: NCT01862315
Last Updated: 2026-07-01
Results Overview
Treatment evaluation will be done using RECIST (version 1.1). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
6 months
Results posted on
2026-07-01
Participant Flow
Participant milestones
| Measure |
No Prior Chemo or Responded/Stable With Prior Chemo
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day30} pump flow rate) on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Patients Who Have Failed Systemic Therapy
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day 30}/ pump flow rate) on day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy
All patients receive will receive gemcitabine alone with HAI FUDR/Dex Gemcitabine (800 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.
dexamethasone
Gemcitabine
MRI
Research blood draws: These are optional
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
5
|
9
|
|
Overall Study
COMPLETED
|
38
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
1
|
Reasons for withdrawal
| Measure |
No Prior Chemo or Responded/Stable With Prior Chemo
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day30} pump flow rate) on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Patients Who Have Failed Systemic Therapy
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day 30}/ pump flow rate) on day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy
All patients receive will receive gemcitabine alone with HAI FUDR/Dex Gemcitabine (800 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.
dexamethasone
Gemcitabine
MRI
Research blood draws: These are optional
|
|---|---|---|---|
|
Overall Study
Due to toxicity
|
4
|
0
|
1
|
Baseline Characteristics
Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)
Baseline characteristics by cohort
| Measure |
No Prior Chemo or Responded/Stable With Prior Chemo
n=42 Participants
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day30} pump flow rate) on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Patients Who Have Failed Systemic Therapy
n=5 Participants
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day 30}/ pump flow rate) on day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy
n=9 Participants
All patients receive will receive gemcitabine alone with HAI FUDR/Dex Gemcitabine (800 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.
dexamethasone
Gemcitabine
MRI
Research blood draws: These are optional
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=9 Participants
|
69 years
n=27 Participants
|
64 years
n=267 Participants
|
63 years
n=265 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
38 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
18 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
56 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
53 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
56 Participants
n=265 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Cohort 1 only
Treatment evaluation will be done using RECIST (version 1.1). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
No Prior Chemo or Responded/Stable With Prior Chemo
n=42 Participants
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day30} pump flow rate) on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Patients Who Have Failed Systemic Therapy
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day 30}/ pump flow rate) on day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy
All patients receive will receive gemcitabine alone with HAI FUDR/Dex Gemcitabine (800 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.
dexamethasone
Gemcitabine
MRI
Research blood draws: These are optional
|
|---|---|---|---|
|
Progression Free Survival for Cohort 1
Participants With Progression Free Survival at 6 months
|
38 Participants
|
0 Participants
|
0 Participants
|
|
Progression Free Survival for Cohort 1
Participants Without Progression Free Survival at 6 months
|
4 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Cohort 2 only
Treatment evaluation will be done using RECIST (version 1.1). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
No Prior Chemo or Responded/Stable With Prior Chemo
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day30} pump flow rate) on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Patients Who Have Failed Systemic Therapy
n=5 Participants
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day 30}/ pump flow rate) on day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy
All patients receive will receive gemcitabine alone with HAI FUDR/Dex Gemcitabine (800 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.
dexamethasone
Gemcitabine
MRI
Research blood draws: These are optional
|
|---|---|---|---|
|
Progression Free Survival for Cohort 2
Withdrew Consent
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Progression Free Survival for Cohort 2
Noncompliant
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Progression Free Survival for Cohort 2
Progression of Disease after initiation of HAI Placement
|
0 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Cohort 3
Treatment evaluation will be done using RECIST (version 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
No Prior Chemo or Responded/Stable With Prior Chemo
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day30} pump flow rate) on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Patients Who Have Failed Systemic Therapy
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day 30}/ pump flow rate) on day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy
n=9 Participants
All patients receive will receive gemcitabine alone with HAI FUDR/Dex Gemcitabine (800 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.
dexamethasone
Gemcitabine
MRI
Research blood draws: These are optional
|
|---|---|---|---|
|
Response for Cohort 3
Partial Response
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Response for Cohort 3
Stable Disease
|
0 Participants
|
0 Participants
|
7 Participants
|
|
Response for Cohort 3
Not evaluable
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Cohort 1
This study will investigate DCE-MRI as potential imaging biomarkers and will measure tumor perfusion parameters and diffusion coefficients before initiating treatment and on follow-up MRI scans during treatment..
Outcome measures
| Measure |
No Prior Chemo or Responded/Stable With Prior Chemo
n=38 Participants
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day30} pump flow rate) on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Patients Who Have Failed Systemic Therapy
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day 30}/ pump flow rate) on day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy
All patients receive will receive gemcitabine alone with HAI FUDR/Dex Gemcitabine (800 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.
dexamethasone
Gemcitabine
MRI
Research blood draws: These are optional
|
|---|---|---|---|
|
Overall Survival
|
84.4 percentage of participants
Interval 68.0 to 93.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Cohort 2 only
This study will investigate diffusion weighted imaging (DWI) as potential imaging biomarkers and will measure tumor perfusion parameters and diffusion coefficients before initiating treatment and on follow-up MRI scans during treatment.
Outcome measures
| Measure |
No Prior Chemo or Responded/Stable With Prior Chemo
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day30} pump flow rate) on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Patients Who Have Failed Systemic Therapy
n=5 Participants
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day 30}/ pump flow rate) on day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy
All patients receive will receive gemcitabine alone with HAI FUDR/Dex Gemcitabine (800 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.
dexamethasone
Gemcitabine
MRI
Research blood draws: These are optional
|
|---|---|---|---|
|
Number of Participants Evaluated for Disease Progression After Initiation of HAI Placement
Withdrew consent
|
—
|
1 Participants
|
—
|
|
Number of Participants Evaluated for Disease Progression After Initiation of HAI Placement
Noncompliant
|
—
|
1 Participants
|
—
|
|
Number of Participants Evaluated for Disease Progression After Initiation of HAI Placement
Progression of Disease after initiation of HAI Placement
|
—
|
3 Participants
|
—
|
Adverse Events
No Prior Chemo or Responded/Stable With Prior Chemo
Serious events: 4 serious events
Other events: 42 other events
Deaths: 25 deaths
Patients Who Have Failed Systemic Therapy
Serious events: 3 serious events
Other events: 5 other events
Deaths: 4 deaths
Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy
Serious events: 4 serious events
Other events: 7 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
No Prior Chemo or Responded/Stable With Prior Chemo
n=42 participants at risk
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day30} pump flow rate) on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Patients Who Have Failed Systemic Therapy
n=5 participants at risk
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day 30}/ pump flow rate) on day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy
n=9 participants at risk
All patients receive will receive gemcitabine alone with HAI FUDR/Dex Gemcitabine (800 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.
dexamethasone
Gemcitabine
MRI
Research blood draws: These are optional
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
1/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Investigations
Decreased Lymphocyte Count
|
2.4%
1/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Investigations
Elevated Lipase
|
4.8%
2/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Investigations
Elevated Serum Amylase
|
2.4%
1/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
2.4%
1/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Infections and infestations
Sepsis
|
2.4%
1/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/42 • 1 year
|
40.0%
2/5 • 1 year
|
11.1%
1/9 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/42 • 1 year
|
0.00%
0/5 • 1 year
|
11.1%
1/9 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/42 • 1 year
|
0.00%
0/5 • 1 year
|
11.1%
1/9 • 1 year
|
|
Psychiatric disorders
Confusion
|
0.00%
0/42 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
General disorders
Death NOS
|
0.00%
0/42 • 1 year
|
0.00%
0/5 • 1 year
|
22.2%
2/9 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/42 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/42 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/42 • 1 year
|
0.00%
0/5 • 1 year
|
11.1%
1/9 • 1 year
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/42 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/42 • 1 year
|
0.00%
0/5 • 1 year
|
11.1%
1/9 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/42 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/42 • 1 year
|
0.00%
0/5 • 1 year
|
11.1%
1/9 • 1 year
|
|
Nervous system disorders
Seizure
|
0.00%
0/42 • 1 year
|
0.00%
0/5 • 1 year
|
11.1%
1/9 • 1 year
|
|
Infections and infestations
Skin infection
|
0.00%
0/42 • 1 year
|
0.00%
0/5 • 1 year
|
11.1%
1/9 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/42 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Investigations
Elevated ALT
|
4.8%
2/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Investigations
Elevated AST
|
4.8%
2/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Investigations
Elevated Bilirubin
|
4.8%
2/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
Other adverse events
| Measure |
No Prior Chemo or Responded/Stable With Prior Chemo
n=42 participants at risk
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day30} pump flow rate) on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Patients Who Have Failed Systemic Therapy
n=5 participants at risk
All patients receive HAI FUDR (\[0.12 mg/kg/day kg 30\] / pump flow rate)\& dexamethasone ({1 mg/m2/day 30}/ pump flow rate) on day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care.
Floxuridine (FUDR)
dexamethasone
Gemcitabine
Oxaliplatin
MRI
Research blood draws: These are optional
|
Pts Who Have Had Prior Oxaliplatin & Have Existing Neuropathy
n=9 participants at risk
All patients receive will receive gemcitabine alone with HAI FUDR/Dex Gemcitabine (800 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.
dexamethasone
Gemcitabine
MRI
Research blood draws: These are optional
|
|---|---|---|---|
|
Investigations
Elevated ALT
|
100.0%
42/42 • 1 year
|
40.0%
2/5 • 1 year
|
22.2%
2/9 • 1 year
|
|
Investigations
Elevated AST
|
81.0%
34/42 • 1 year
|
20.0%
1/5 • 1 year
|
22.2%
2/9 • 1 year
|
|
Investigations
Elevated Bilirubin
|
42.9%
18/42 • 1 year
|
0.00%
0/5 • 1 year
|
22.2%
2/9 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
38.1%
16/42 • 1 year
|
60.0%
3/5 • 1 year
|
77.8%
7/9 • 1 year
|
|
Investigations
Elevated Alk Phos
|
31.0%
13/42 • 1 year
|
20.0%
1/5 • 1 year
|
22.2%
2/9 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
31.0%
13/42 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
26.2%
11/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
19.0%
8/42 • 1 year
|
20.0%
1/5 • 1 year
|
55.6%
5/9 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.9%
5/42 • 1 year
|
20.0%
1/5 • 1 year
|
22.2%
2/9 • 1 year
|
|
Investigations
Decreased Lymphocyte Count
|
11.9%
5/42 • 1 year
|
40.0%
2/5 • 1 year
|
33.3%
3/9 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.1%
3/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
3/42 • 1 year
|
0.00%
0/5 • 1 year
|
11.1%
1/9 • 1 year
|
|
Gastrointestinal disorders
Ascites
|
7.1%
3/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
7.1%
3/42 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Blood and lymphatic system disorders
Decreased Platelet Count
|
7.1%
3/42 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
2/42 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Surgical and medical procedures
Liver Surgery
|
4.8%
2/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
General disorders
Fever
|
23.8%
10/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
General disorders
Fatigue
|
16.7%
7/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
General disorders
Chills
|
2.4%
1/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/42 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/42 • 1 year
|
0.00%
0/5 • 1 year
|
11.1%
1/9 • 1 year
|
|
Psychiatric disorders
Confusion
|
0.00%
0/42 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/42 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/42 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Investigations
Lipase increased
|
0.00%
0/42 • 1 year
|
20.0%
1/5 • 1 year
|
11.1%
1/9 • 1 year
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/42 • 1 year
|
40.0%
2/5 • 1 year
|
11.1%
1/9 • 1 year
|
|
Investigations
White blood cell decreased
|
0.00%
0/42 • 1 year
|
40.0%
2/5 • 1 year
|
11.1%
1/9 • 1 year
|
Additional Information
Dr. William Jarnagin, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-7601
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place