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| Sponsor: | Weill Medical College of Cornell University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00061932 |
Purpose
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with irinotecan may kill more tumor cells.
PURPOSE: This phase II trial is studying how well bortezomib with or without irinotecan works in treating patients with gastroesophageal junction or stomach cancer that can not be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: bortezomib Drug: irinotecan hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study Of PS341 Alone Or In Combination With Irinotecan In Patients With Adenocarcinoma Of The Gastroesophageal Junction (GEJ) Or Stomach |
| Estimated Enrollment: | 58 |
| Study Start Date: | May 2003 |
| Estimated Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Stratum 1 (previously untreated): Experimental
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.
|
Drug: bortezomib
Given IV
Drug: irinotecan hydrochloride
Given IV
|
|
Stratum 2 (previously treated, closed to accrual 9/19/2006: Experimental
Patients receive bortezomib as in stratum 1.
|
Drug: bortezomib
Given IV
|
OBJECTIVES:
OUTLINE: Patients are stratified (stratum 2 closed to accrual as of 9/19/2006) according to prior chemotherapy for advanced disease (yes vs no).
In both strata, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 33-58 patients (18-33 previously untreated patients and 15-25 previously treated patients [(closed to accrual as of 9/19/2006)]) will be accrued for this study within 12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the gastroesophageal junction or stomach
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10467 | |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| NYU Cancer Institute at New York University Medical Center | |
| New York, New York, United States, 10016 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Canada, Ontario | |
| Ottawa Hospital Regional Cancer Centre - General Campus | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Study Chair: | Allyson J. Ocean, MD | Weill Medical College of Cornell University |
More Information
| Study ID Numbers: | CDR0000302448, NYWCCC-0103672, NCI-5941 |
| Study First Received: | June 5, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00061932 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
adenocarcinoma of the stomach recurrent gastric cancer stage III gastric cancer stage IV gastric cancer |
|
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Irinotecan Bortezomib Enzyme Inhibitors Pharmacologic Actions Camptothecin |
Protease Inhibitors Neoplasms Neoplasms by Site Digestive System Diseases Stomach Diseases Therapeutic Uses Stomach Neoplasms Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic |