Bryostatin 1 in Treating Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00003220
First received: November 1, 1999
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: bryostatin 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Bryostatin 1 in Patients With Metastatic Colo-Rectal Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Study Start Date: February 1998
Study Completion Date: June 2001
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003220

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Philip A. Philip, MD, PhD, FRCP Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00003220     History of Changes
Other Study ID Numbers: CDR0000066081, P30CA022453, WSU-D-1457, NCI-T97-0065
Study First Received: November 1, 1999
Last Updated: April 3, 2013
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Colorectal Neoplasms
Adenocarcinoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bryostatin 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014