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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006081 |
Purpose
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 combining bryostatin 1 and paclitaxel in treating patients who have unresectable locally advanced or metastatic stomach cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Gastric Cancer |
Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of Bryostatin-1 (NSC 339555) Plus Paclitaxel in Patients With Metastatic or Unresectable Locally Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction |
| Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment continues every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive up to 4 more courses after achieving CR.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable disease
The following are not considered measurable:
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, Texas | |
| CCOP - M.D. Anderson Research Base | |
| Houston, Texas, United States, 77030-4009 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Jaffer A. Ajani, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000068069, MDA-ID-99203, NCI-T99-0103 |
| Study First Received: | August 3, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006081 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III gastric cancer stage IV gastric cancer stage III esophageal cancer |
stage IV esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus |
|
Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Esophageal Neoplasms Mitosis Modulators Antimitotic Agents Pharmacologic Actions Carcinoma Neoplasms Stomach Diseases |
Digestive System Diseases Neoplasms by Site Paclitaxel Therapeutic Uses Head and Neck Neoplasms Stomach Neoplasms Tubulin Modulators Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |