Bryostatin 1 in Treating Patients With Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with metastatic colorectal cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Bryostatin 1 in Patients With Metastatic Colo-Rectal Adenocarcinoma|
|Study Start Date:||February 1998|
|Study Completion Date:||June 2001|
|Primary Completion Date:||November 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the efficacy of bryostatin 1 administered as a 24 hour intravenous infusion every week for 3 weeks during a 4 week course of therapy in patients with colorectal cancer. II. Determine the response duration, time to progression, and survival time in this patient population. III. Determine the qualitative and quantitative toxic effects of bryostatin 1 on this schedule in this patient population.
OUTLINE: Patients are treated with bryostatin 1 as a 24 hour continuous intravenous infusion weekly for 3 weeks followed by 1 week of rest. Courses are repeated every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients who have no toxic effects after the completion of the first course of therapy may have the dose of bryostatin 1 escalated by 1 dose level in subsequent courses. Patients are followed for response duration and time to treatment failure.
PROJECTED ACCRUAL: A total of 13-26 patients will be accrued for this study within 18 months.
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Veterans Affairs Medical Center - Detroit|
|Detroit, Michigan, United States, 48201-1932|
|Study Chair:||Philip A. Philip, MD, PhD, FRCP||Barbara Ann Karmanos Cancer Institute|