Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach
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|ClinicalTrials.gov Identifier: NCT00061932|
Recruitment Status : Completed
First Posted : June 6, 2003
Results First Posted : June 3, 2015
Last Update Posted : June 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Gastroesophageal Junction Diffuse Adenocarcinoma of the Stomach Intestinal Adenocarcinoma of the Stomach Mixed Adenocarcinoma of the Stomach Recurrent Gastric Cancer Stage IIIB Gastric Cancer Stage IIIC Gastric Cancer Stage IV Gastric Cancer||Drug: bortezomib Drug: irinotecan||Phase 2|
I. To determine the response rate for the combination of irinotecan and PS 341 in patients with previously untreated adenocarcinoma of the stomach or GEJ.
II. To determine the response rate for PS341 in patients with previously treated adenocarcinoma of the stomach or GEJ.
III. To determine the toxicities and recovery from toxicities for patients receiving PS 341 alone or in combination with irinotecan IV. To perform GeneChip analysis on biopsy specimens prior to and subsequent to treatment with PS341 to determine changes in patterns of gene expression
OUTLINE: Patients are stratified (stratum 2 closed to accrual as of 9/19/2006) according to prior chemotherapy for advanced disease (yes vs no).
STRATUM 1 (Previously untreated patients): 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.
STRATUM 2 (Previously treated patients) (closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
In both strata, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of PS-341 Alone or in Combination With Irinotecan in Patients With Adenocarcinoma of the Gastroesophageal Junction (GEJ) or Stomach|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||November 2013|
Experimental: Stratum 1 (previously untreated)
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.
Experimental: Stratum 2 (previously treated)
(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
- True Response Rate Evaluated for the Combination of Irinotecan and PS341 by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 6 years ]Tumor response was assessed every eight weeks by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria
- Change in Patterns of Gene Expression Pre- and Post-treatment Performed by GeneChip Analysis [ Time Frame: Baseline to 6 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061932
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467-2490|
|Principal Investigator:||Allyson Ocean||Montefiore Medical Center|