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Bryostatin 1 in Treating Patients With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bryostatin 1
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veterans Affairs Medical Center - Detroit
  • Barbara Ann Karmanos Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
April 3, 2013
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003220
Brief Title
Bryostatin 1 in Treating Patients With Metastatic Colorectal Cancer
Official Title
Phase II Study of Bryostatin 1 in Patients With Metastatic Colo-Rectal Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
November 2000 (Actual)
Study Completion Date
June 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bryostatin 1

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip A. Philip, MD, PhD, FRCP
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Veterans Affairs Medical Center - Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1932
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

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Bryostatin 1 in Treating Patients With Metastatic Colorectal Cancer

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