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FR901228 in Treating Patients With Previously Treated Unresectable Locally Advanced or Metastatic Colorectal Cancer

Phase 2
Completed
Conditions
Colorectal Cancer
Registration Number
NCT00077337
Lead Sponsor
SWOG Cancer Research Network
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with unresectable locally advanced or metastatic colorectal cancer.

Detailed Description

OBJECTIVES:

* Determine the confirmed response (complete and partial) in patients with previously treated unresectable locally advanced or metastatic colorectal cancer treated with FR901228 (depsipeptide).

* Determine the time to treatment failure and overall survival of patients treated with this drug.

* Determine the qualitative and quantitative toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks until disease progression and then every 3 months until 1 year after study entry and then every 6 months until 3 years after study entry.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 4-10 months.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (88)

MBCCOP - Gulf Coast

πŸ‡ΊπŸ‡Έ

Mobile, Alabama, United States

CCOP - Western Regional, Arizona

πŸ‡ΊπŸ‡Έ

Phoenix, Arizona, United States

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

πŸ‡ΊπŸ‡Έ

Phoenix, Arizona, United States

Veterans Affairs Medical Center - Tucson

πŸ‡ΊπŸ‡Έ

Tucson, Arizona, United States

Arizona Cancer Center at University of Arizona Health Sciences Center

πŸ‡ΊπŸ‡Έ

Tucson, Arizona, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

πŸ‡ΊπŸ‡Έ

Little Rock, Arkansas, United States

Veterans Affairs Medical Center - Little Rock

πŸ‡ΊπŸ‡Έ

Little Rock, Arkansas, United States

City of Hope Comprehensive Cancer Center

πŸ‡ΊπŸ‡Έ

Duarte, California, United States

Veterans Affairs Medical Center - Loma Linda (Pettis)

πŸ‡ΊπŸ‡Έ

Loma Linda, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

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MBCCOP - Gulf Coast
πŸ‡ΊπŸ‡ΈMobile, Alabama, United States

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