Phase II Study of Bryostatin 1 in Patients With Metastatic Colo-Rectal Adenocarcinoma
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.
Interventional
Primary Purpose: Treatment
Philip A. Philip, MD, PhD, FRCP
Study Chair
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
CDR0000066081
NCT00003220
February 1998
June 2001
Name | Location |
---|---|
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |