Trial Outcomes & Findings for A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers (NCT NCT00660699)
NCT ID: NCT00660699
Last Updated: 2015-05-27
Results Overview
Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
1 month after completion of treatment (treatment lasts approximately 19 weeks)
Results posted on
2015-05-27
Participant Flow
The study opened to participants enrollment on 09/14/2002 and closed to participant enrollment on 11/06/2012
Participant milestones
| Measure |
Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
Baseline characteristics by cohort
| Measure |
Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)
n=50 Participants
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Age, Continuous
|
59 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
|
Overall stage
I
|
3 participants
n=99 Participants
|
|
Overall stage
II
|
46 participants
n=99 Participants
|
|
Overall stage
III
|
1 participants
n=99 Participants
|
|
Overall stage
IV
|
0 participants
n=99 Participants
|
|
Disease type
Pancreatic cancer
|
29 participants
n=99 Participants
|
|
Disease type
Biliary tract cancer
|
12 participants
n=99 Participants
|
|
Disease type
Ampullary cancer
|
9 participants
n=99 Participants
|
|
T-stage
1
|
2 participants
n=99 Participants
|
|
T-stage
2
|
11 participants
n=99 Participants
|
|
T-stage
3
|
35 participants
n=99 Participants
|
|
T-stage
4
|
2 participants
n=99 Participants
|
|
N-stage
0
|
10 participants
n=99 Participants
|
|
N-stage
1
|
36 participants
n=99 Participants
|
|
N-stage
X
|
4 participants
n=99 Participants
|
|
Differentiation
Well
|
4 participants
n=99 Participants
|
|
Differentiation
Moderate
|
17 participants
n=99 Participants
|
|
Differentiation
Poor
|
28 participants
n=99 Participants
|
|
Differentiation
Not reported
|
1 participants
n=99 Participants
|
|
Lymphovascular involvement
Yes
|
36 participants
n=99 Participants
|
|
Lymphovascular involvement
No
|
9 participants
n=99 Participants
|
|
Lymphovascular involvement
Not Reported
|
5 participants
n=99 Participants
|
|
CA 19-9 (tumor marker)
<40
|
34 participants
n=99 Participants
|
|
CA 19-9 (tumor marker)
40-100
|
11 participants
n=99 Participants
|
|
CA 19-9 (tumor marker)
>100
|
5 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 month after completion of treatment (treatment lasts approximately 19 weeks)Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0
Outcome measures
| Measure |
Arm 1
n=48 Participants
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Incidence of Severe Toxicities
|
20 percentage of participants
|
SECONDARY outcome
Timeframe: 30 days after completion of treatment (treatment lasts approximately 19 weeks)Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome.
Outcome measures
| Measure |
Arm 1
n=48 Participants
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Toxicities Associated With Treatment (Grade 1-2)
Mucositis
|
31 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 1-2)
Nausea
|
48 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 1-2)
Vomiting
|
23 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 1-2)
Diarrhea
|
31 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 1-2)
Dehydration
|
17 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 1-2)
Weight loss
|
27 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 1-2)
Fatigue
|
67 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 1-2)
Renal toxicity
|
13 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 1-2)
Neutropenia
|
46 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 1-2)
Anemia
|
65 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 1-2)
Thrombocytopenia
|
46 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 1-2)
Hepatotoxicity
|
69 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 1-2)
Infection
|
13 percentage of participants
|
SECONDARY outcome
Timeframe: 30 days after completion of treatment (treatment lasts approximately 19 weeks)Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome.
Outcome measures
| Measure |
Arm 1
n=48 Participants
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Toxicities Associated With Treatment (Grade 3-4)
Mucositis
|
2 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 3-4)
Nausea
|
4 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 3-4)
Vomiting
|
4 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 3-4)
Diarrhea
|
15 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 3-4)
Dehydration
|
4 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 3-4)
Weight loss
|
0 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 3-4)
Fatigue
|
8 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 3-4)
Renal toxicity
|
0 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 3-4)
Hepatotoxicity
|
4 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 3-4)
Infection
|
15 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 3-4)
Neutropenia
|
23 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 3-4)
Anemia
|
4 percentage of participants
|
|
Toxicities Associated With Treatment (Grade 3-4)
Thrombocytopenia
|
6 percentage of participants
|
SECONDARY outcome
Timeframe: Median follow-up was 24 months (range 3.2-97 months)DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.
Outcome measures
| Measure |
Arm 1
n=48 Participants
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Disease Free Survival (DFS) - Median
Pancreatic cancer
|
9.6 months
Interval 5.8 to 11.6
|
|
Disease Free Survival (DFS) - Median
Biliary/ampullary cancer
|
12.7 months
Interval 7.9 to 18.9
|
SECONDARY outcome
Timeframe: Median follow-up was 24 months (range 3.2-97 months)Population: 30 out of 48 participants completed all components of the study therapy.
DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.
Outcome measures
| Measure |
Arm 1
n=30 Participants
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Disease Free Survival (DFS) - Median
Pancreatic cancer
|
12.8 months
Interval 5.9 to 17.5
|
|
Disease Free Survival (DFS) - Median
Biliary cancer/ampullary cancer
|
15.0 months
Interval 8.1 to 18.9
|
SECONDARY outcome
Timeframe: Median follow-up was 24 months (range 3.2-97 months)OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.
Outcome measures
| Measure |
Arm 1
n=48 Participants
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Overall Survival (OS) - Median
Biliary cancer/ampullary cancer
|
23.8 months
Interval 11.4 to 47.0
|
|
Overall Survival (OS) - Median
Pancreatic cancer
|
17.6 months
Interval 8.6 to 23.8
|
SECONDARY outcome
Timeframe: 1 yearOS was defined as the time from the initiation of treatment to death from any cause or last follow-up
Outcome measures
| Measure |
Arm 1
n=48 Participants
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Overall Survival (OS)
Pancreatic cancer
|
60.7 percentage of participants
Interval 45.0 to 81.8
|
|
Overall Survival (OS)
Biliary/ampullary cancer
|
75.0 percentage of participants
Interval 58.0 to 96.6
|
SECONDARY outcome
Timeframe: 2 yearsOS was defined as the time from the initiation of treatment to death from any cause or last follow-up
Outcome measures
| Measure |
Arm 1
n=48 Participants
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Overall Survival (OS)
Pancreatic cancer
|
32.1 percentage of participants
Interval 18.8 to 55.1
|
|
Overall Survival (OS)
Biliary/ampullary cancer
|
49.1 percentage of participants
Interval 31.2 to 77.3
|
SECONDARY outcome
Timeframe: Median follow-up was 24 months (range 3.2-97 months)Population: 30 out of 48 participants completed all components of study treatment.
OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.
Outcome measures
| Measure |
Arm 1
n=30 Participants
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Overall Survival (OS) - Median
Pancreatic cancer
|
24.5 months
Interval 9.7 to 29.4
|
|
Overall Survival (OS) - Median
Biliary cancer/ampullary cancer
|
23.8 months
Interval 12.8 to 70.4
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 30 out of 48 participants completed all components of study treatment.
OS was defined as the time from the initiation of treatment to death from any cause or last follow-up
Outcome measures
| Measure |
Arm 1
n=30 Participants
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Overall Survival (OS)
Biliary/ampullary cancer
|
81.2 percentage of participants
Interval 64.2 to 100.0
|
|
Overall Survival (OS)
Pancreatic cancer
|
78.6 percentage of participants
Interval 59.0 to 100.0
|
POST_HOC outcome
Timeframe: Median follow-up was 24 months (range 3.2-97 months)Outcome measures
| Measure |
Arm 1
n=48 Participants
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Incidence of Disease Recurrence
|
83 percentage of participants
|
Adverse Events
Arm 1
Serious events: 16 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=48 participants at risk
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Gastrointestinal disorders
Abdominal cystic lesion
|
2.1%
1/48
|
|
Respiratory, thoracic and mediastinal disorders
Cavitary lung lesion
|
2.1%
1/48
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/48
|
|
General disorders
Death
|
2.1%
1/48
|
|
Gastrointestinal disorders
Dehydration
|
2.1%
1/48
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
2/48
|
|
Nervous system disorders
Dizziness
|
2.1%
1/48
|
|
General disorders
Edema
|
2.1%
1/48
|
|
Infections and infestations
Febrile neutropenia
|
2.1%
1/48
|
|
General disorders
Fever
|
6.2%
3/48
|
|
General disorders
Generalized weakness
|
2.1%
1/48
|
|
Investigations
Granulocytes
|
2.1%
1/48
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.1%
1/48
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.1%
1/48
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.1%
1/48
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.1%
1/48
|
|
Vascular disorders
Hypotension
|
2.1%
1/48
|
|
Gastrointestinal disorders
Ileus, GI
|
2.1%
1/48
|
|
Infections and infestations
Infection
|
12.5%
6/48
|
|
Investigations
Leukopenia
|
2.1%
1/48
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/48
|
|
General disorders
Pain
|
2.1%
1/48
|
|
Investigations
Platelets
|
2.1%
1/48
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.1%
1/48
|
|
Nervous system disorders
Syncope
|
2.1%
1/48
|
|
Vascular disorders
Thrombosis/embolism
|
2.1%
1/48
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
2/48
|
Other adverse events
| Measure |
Arm 1
n=48 participants at risk
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
|
|---|---|
|
Investigations
Alkaline phosphatase
|
37.5%
18/48
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.2%
2/48
|
|
Metabolism and nutrition disorders
Anorexia
|
22.9%
11/48
|
|
Psychiatric disorders
Anxiety
|
2.1%
1/48
|
|
Gastrointestinal disorders
Ascites
|
4.2%
2/48
|
|
Investigations
BUN
|
4.2%
2/48
|
|
Investigations
Bilirubin
|
2.1%
1/48
|
|
General disorders
Chills
|
4.2%
2/48
|
|
Gastrointestinal disorders
Colitis
|
2.1%
1/48
|
|
Gastrointestinal disorders
Constipation
|
16.7%
8/48
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
2/48
|
|
Renal and urinary disorders
Creatinine
|
12.5%
6/48
|
|
Gastrointestinal disorders
Dehydration
|
18.8%
9/48
|
|
Psychiatric disorders
Depression
|
10.4%
5/48
|
|
Gastrointestinal disorders
Diarrhea
|
43.8%
21/48
|
|
Nervous system disorders
Dizziness
|
2.1%
1/48
|
|
Nervous system disorders
Dysgeusia
|
2.1%
1/48
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
4/48
|
|
Gastrointestinal disorders
Dysphagia
|
2.1%
1/48
|
|
General disorders
Edema
|
6.2%
3/48
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.1%
1/48
|
|
Eye disorders
Eye
|
2.1%
1/48
|
|
General disorders
Fatigue
|
70.8%
34/48
|
|
General disorders
Fever
|
4.2%
2/48
|
|
Gastrointestinal disorders
Flatulence
|
2.1%
1/48
|
|
Vascular disorders
Flushing
|
2.1%
1/48
|
|
Investigations
Granulocytes
|
58.3%
28/48
|
|
Skin and subcutaneous tissue disorders
Hand/foot syndrome
|
10.4%
5/48
|
|
Gastrointestinal disorders
Hematochezia
|
2.1%
1/48
|
|
Renal and urinary disorders
Hematuria
|
4.2%
2/48
|
|
Blood and lymphatic system disorders
Hemoglobin
|
66.7%
32/48
|
|
General disorders
Hemorrhage
|
4.2%
2/48
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.3%
4/48
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
24/48
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.2%
2/48
|
|
Vascular disorders
Hypertension
|
2.1%
1/48
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
52.1%
25/48
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
16/48
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.2%
2/48
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.8%
9/48
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.1%
1/48
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.8%
9/48
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.1%
1/48
|
|
Vascular disorders
Hypotension
|
6.2%
3/48
|
|
Infections and infestations
Infection
|
14.6%
7/48
|
|
Psychiatric disorders
Insomnia
|
8.3%
4/48
|
|
Investigations
Leukopenia
|
66.7%
32/48
|
|
Investigations
Lymphopenia
|
68.8%
33/48
|
|
Gastrointestinal disorders
Mucositis
|
22.9%
11/48
|
|
Gastrointestinal disorders
Nausea
|
47.9%
23/48
|
|
Renal and urinary disorders
Nocturia
|
2.1%
1/48
|
|
Nervous system disorders
Other neurologic
|
2.1%
1/48
|
|
General disorders
Pain
|
52.1%
25/48
|
|
Vascular disorders
Phlebitis
|
2.1%
1/48
|
|
Investigations
Platelets
|
50.0%
24/48
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
3/48
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
2/48
|
|
Investigations
SGOT/SGPT
|
54.2%
26/48
|
|
Nervous system disorders
Sensory neuropathy
|
4.2%
2/48
|
|
Skin and subcutaneous tissue disorders
Skin-photosensitivity
|
2.1%
1/48
|
|
Gastrointestinal disorders
Stomatitis
|
4.2%
2/48
|
|
General disorders
Sweating
|
2.1%
1/48
|
|
Vascular disorders
Thrombosis/embolism
|
4.2%
2/48
|
|
Infections and infestations
Thrush
|
2.1%
1/48
|
|
Renal and urinary disorders
Urinary retention
|
2.1%
1/48
|
|
Renal and urinary disorders
Urinary tract infection
|
6.2%
3/48
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/48
|
|
Gastrointestinal disorders
Weight loss
|
16.7%
8/48
|
Additional Information
Benjamin Tan, M.D.
Washington University School of Medicine
Phone: 314-362-5740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place