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Phase II Study of Bryostatin 1 in Patients With Metastatic Colo-Rectal Adenocarcinoma

Phase 2
Not Enrolling
Colorectal Cancer

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Trial Information

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

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed colorectal cancer
Unresectable disease Measurable disease No uncontrolled brain metastases

PATIENT CHARACTERISTICS: Age: Any age Performance status: SWOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal
(ULN) AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN
Other: No active infection Not pregnant or nursing Negative pregnancy test for
premenopausal women Fertile patients must use effective contraception No concurrent
uncontrolled systemic disorders No prior malignant disease within the past year except in
situ carcinoma of the cervix or curatively treated basal cell carcinoma of the skin No
history of allergy to bryostatin 1 or its vehicle

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: Only
one prior chemotherapy regimen in the adjuvant or metastatic setting allowed At least 3
weeks since prior chemotherapy (6 weeks for nitrosoureas) No other concurrent chemotherapy
Endocrine therapy: No concurrent hormonal therapy (except contraceptives, appetite
stimulants and replacement steroids) Radiotherapy: At least 3 weeks since prior
radiotherapy No concurrent radiation therapy No concurrent palliative radiation therapy to
only site of measurable disease Surgery: Not specified Other: At least 1 month since prior
use of any other investigational agent No concurrent use of experimental medications

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Philip A. Philip, MD, PhD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

February 1998

Completion Date:

June 2001

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932