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Sponsors and Collaborators: |
Norris Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006389 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin 1 may increase the effectiveness of cisplatin by making tumor cells more sensitive to the drug. Combining cisplatin with bryostatin 1 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients who have metastatic or unresectable stomach cancer.
Condition | Intervention | Phase |
---|---|---|
Gastric Cancer |
Drug: bryostatin 1 Drug: cisplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer |
Study Start Date: | November 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 15-62 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
City of Hope Medical Group | |
Pasadena, California, United States, 91105 | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90033-0804 |
Study Chair: | Heinz-Josef Lenz, MD | Norris Comprehensive Cancer Center |
Study ID Numbers: | CDR0000068267, LAC-USC-3S001, CHNMC-PHII-22, NCI-T99-0040 |
Study First Received: | October 4, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006389 History of Changes |
Health Authority: | United States: Federal Government |
stage III gastric cancer stage IV gastric cancer |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Immunologic Factors Radiation-Sensitizing Agents Cisplatin |
Gastrointestinal Diseases Stomach Neoplasms Adjuvants, Immunologic Gastrointestinal Neoplasms Bryostatin 1 Stomach Cancer |
Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Adjuvants, Immunologic Bryostatin 1 Pharmacologic Actions Neoplasms |
Neoplasms by Site Digestive System Diseases Stomach Diseases Radiation-Sensitizing Agents Cisplatin Stomach Neoplasms Therapeutic Uses Gastrointestinal Neoplasms |