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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| 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: Bryostatin-1 Drug: Paclitaxel (Taxol) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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 |
| Enrollment: | 37 |
| Study Start Date: | June 2000 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bryostatin-1 + Taxol |
Drug: Bryostatin-1
40 mcg/m2 one-hour infusion 24 hours after each dose of paclitaxel (i.e., day 2, 9, 16).
Drug: Paclitaxel (Taxol)
80 mg/m^2 one-hour infusion weekly x 3 every 4 weeks
Other Name: Taxol
|
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 |
Inclusion Criteria:
Exclusion Criteria:
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
| Responsible Party: | Jaffer Ajani, M.D., UT MD Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00006081 History of Changes |
| Other Study ID Numbers: | ID99-203, U01CA070172, P30CA016672, MDA-ID-99203, NCI-T99-0103, CDR0000068069 |
| Study First Received: | August 3, 2000 |
| Last Updated: | August 2, 2010 |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board |
|
stage III gastric cancer stage IV gastric cancer stage III esophageal cancer |
stage IV esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus |
|
Adenocarcinoma Esophageal Diseases Esophageal Neoplasms Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms |
Stomach Diseases Bryostatin 1 Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |