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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005599 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 and paclitaxel in treating patients who have locally advanced or metastatic esophageal cancer or stomach cancer.
Condition | Intervention | Phase |
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Esophageal Cancer Gastric Cancer |
Drug: bryostatin 1 Drug: paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trail of Bryostatin-1 and Paclitaxel in Patients With Advanced Esophageal Cancer |
Study Start Date: | February 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 1 hour on day 1 and bryostatin 1 IV over 24 hours on day 2 weekly for 2 weeks. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Quality of life is assessed at baseline, after courses 1 and 2, and then after every 2 courses thereafter.
PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 1-2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or carcinoma of the gastroesophageal (GE) junction
Measurable disease
No truly nonmeasurable lesions only:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
No other active malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, New York | |
Albert Einstein Clinical Cancer Center | |
Bronx, New York, United States, 10467 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Gary K. Schwartz, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000067712, MSKCC-99094, MSKCC-FDR001826, NCI-250 |
Study First Received: | May 2, 2000 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00005599 History of Changes |
Health Authority: | United States: Federal Government |
stage III gastric cancer stage IV gastric cancer recurrent gastric cancer stage III esophageal cancer |
stage IV esophageal cancer recurrent esophageal cancer squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus |
Immunologic Factors Gastrointestinal Diseases Esophageal Neoplasms Squamous Cell Carcinoma Stomach Diseases Stomach Neoplasms Digestive System Neoplasms Adjuvants, Immunologic Esophageal Cancer Bryostatin 1 Antimitotic Agents Recurrence Carcinoma |
Digestive System Diseases Esophageal Disorder Paclitaxel Head and Neck Neoplasms Epidermoid Carcinoma Tubulin Modulators Gastrointestinal Neoplasms Esophageal Diseases Stomach Cancer Adenocarcinoma Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Gastrointestinal Diseases Esophageal Neoplasms Mitosis Modulators Physiological Effects of Drugs Adjuvants, Immunologic Antimitotic Agents Bryostatin 1 Pharmacologic Actions |
Neoplasms Digestive System Diseases Neoplasms by Site Stomach Diseases Paclitaxel Therapeutic Uses Stomach Neoplasms Head and Neck Neoplasms Tubulin Modulators Gastrointestinal Neoplasms Esophageal Diseases Antineoplastic Agents, Phytogenic |