Trial Outcomes & Findings for Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach (NCT NCT00061932)
NCT ID: NCT00061932
Last Updated: 2021-02-02
Results Overview
CT or MRI imaging scans of measurable lesions were obtained at baseline and every 8 weeks thereafter. Responses were classified according to RECIST criteria (version 1.0)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Up to 6 years
Results posted on
2021-02-02
Participant Flow
A total of 41 patients were enrolled from 6 institutions between April 2003 and September 2006
Participant milestones
| Measure |
Stratum 1 (Previously Untreated)
Patients receive bortezomib IV 1.3 mg/m2 over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV 125 mg/m2 over 90 minutes on days 1 and 8.
bortezomib: Given IV (1.3 mg/m2)
irinotecan: Given IV (125 mg/m2)
|
Stratum 2 (Previously Treated)
(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
bortezomib: Given IV
irinotecan: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
12
|
|
Overall Study
COMPLETED
|
16
|
8
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
Reasons for withdrawal
| Measure |
Stratum 1 (Previously Untreated)
Patients receive bortezomib IV 1.3 mg/m2 over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV 125 mg/m2 over 90 minutes on days 1 and 8.
bortezomib: Given IV (1.3 mg/m2)
irinotecan: Given IV (125 mg/m2)
|
Stratum 2 (Previously Treated)
(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
bortezomib: Given IV
irinotecan: Given IV
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
4
|
Baseline Characteristics
Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach
Baseline characteristics by cohort
| Measure |
Stratum 1 (Previously Untreated)
n=29 Participants
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.
bortezomib: Given IV
irinotecan: Given IV
|
Stratum 2 (Previously Treated)
n=12 Participants
(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
bortezomib: Given IV
irinotecan: Given IV
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
n=99 Participants
|
54.5 years
n=107 Participants
|
56.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
24 participants
n=99 Participants
|
9 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 6 yearsCT or MRI imaging scans of measurable lesions were obtained at baseline and every 8 weeks thereafter. Responses were classified according to RECIST criteria (version 1.0)
Outcome measures
| Measure |
Stratum 1 (Previously Untreated)
n=29 Participants
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.
bortezomib: Given IV
irinotecan: Given IV
|
Stratum 2 (Previously Treated)
n=12 Participants
(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
bortezomib: Given IV
irinotecan: Given IV
|
|---|---|---|
|
True Response Rate Evaluated for the Combination of Irinotecan and PS341 by Response Evaluation Criteria in Solid Tumors (RECIST)
|
3 participants
Interval 2.2 to 27.4
|
1 participants
Interval 0.2 to 38.5
|
SECONDARY outcome
Timeframe: Baseline to 6 yearsNumber of Participants with a Change in Gene Expression from Pre to Post Treatment
Outcome measures
| Measure |
Stratum 1 (Previously Untreated)
n=10 Participants
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.
bortezomib: Given IV
irinotecan: Given IV
|
Stratum 2 (Previously Treated)
n=2 Participants
(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
bortezomib: Given IV
irinotecan: Given IV
|
|---|---|---|
|
Change in Patterns of Gene Expression Pre- and Post-treatment Performed by GeneChip Analysis
|
2 Participants
|
2 Participants
|
Adverse Events
Stratum 1 (Previously Untreated)
Serious events: 24 serious events
Other events: 25 other events
Deaths: 0 deaths
Stratum 2 (Previously Treated)
Serious events: 8 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stratum 1 (Previously Untreated)
n=29 participants at risk
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.
bortezomib: Given IV
irinotecan: Given IV
|
Stratum 2 (Previously Treated)
n=12 participants at risk
(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
bortezomib: Given IV
irinotecan: Given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
17.2%
5/29 • Number of events 5
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Leukocytopenia
|
27.6%
8/29 • Number of events 8
|
0.00%
0/12
|
|
Investigations
Neutropenia
|
27.6%
8/29 • Number of events 8
|
0.00%
0/12
|
|
Investigations
Thrombocytopenia
|
10.3%
3/29 • Number of events 3
|
16.7%
2/12 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.8%
4/29 • Number of events 4
|
0.00%
0/12
|
|
Gastrointestinal disorders
Anorexia
|
3.4%
1/29 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Cardiac disorders
Heart stoppage
|
3.4%
1/29 • Number of events 1
|
0.00%
0/12
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
3.4%
1/29 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dehydration
|
17.2%
5/29 • Number of events 5
|
25.0%
3/12 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
27.6%
8/29 • Number of events 8
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/29
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/29
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Edema: trunk/genital
|
0.00%
0/29
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Fatigue
|
17.2%
5/29 • Number of events 5
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.8%
4/29 • Number of events 4
|
0.00%
0/12
|
|
Renal and urinary disorders
Hemorrhage, GU: Urinary NOS
|
0.00%
0/29
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.9%
2/29 • Number of events 2
|
0.00%
0/12
|
|
Vascular disorders
Hypotension
|
6.9%
2/29 • Number of events 2
|
0.00%
0/12
|
|
Infections and infestations
Infection: Lung
|
0.00%
0/29
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/29
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
17.2%
5/29 • Number of events 5
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Obstruction: Small bowel NOS
|
13.8%
4/29 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain: right hip
|
0.00%
0/29
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
3/29 • Number of events 3
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: desquamation
|
6.9%
2/29 • Number of events 2
|
0.00%
0/12
|
|
Gastrointestinal disorders
Vomiting
|
20.7%
6/29 • Number of events 6
|
8.3%
1/12 • Number of events 1
|
Other adverse events
| Measure |
Stratum 1 (Previously Untreated)
n=29 participants at risk
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.
bortezomib: Given IV
irinotecan: Given IV
|
Stratum 2 (Previously Treated)
n=12 participants at risk
(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
bortezomib: Given IV
irinotecan: Given IV
|
|---|---|---|
|
General disorders
Fever (in the absence of neutropenia)
|
10.3%
3/29 • Number of events 3
|
0.00%
0/12
|
|
Gastrointestinal disorders
Flatulence
|
13.8%
4/29 • Number of events 4
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.3%
3/29 • Number of events 3
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Neuropathy: Sensory
|
13.8%
4/29 • Number of events 4
|
0.00%
0/12
|
|
General disorders
Chills
|
13.8%
4/29 • Number of events 4
|
0.00%
0/12
|
|
General disorders
Edema:limbs
|
13.8%
4/29 • Number of events 4
|
25.0%
3/12 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
17.2%
5/29 • Number of events 5
|
41.7%
5/12 • Number of events 5
|
|
Psychiatric disorders
Insomnia
|
10.3%
3/29 • Number of events 3
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Rash: desquamation
|
10.3%
3/29 • Number of events 3
|
8.3%
1/12 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60