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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

🇺🇸

Mobile, Alabama, United States

CCOP - Western Regional, Arizona

🇺🇸

Phoenix, Arizona, United States

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

🇺🇸

Phoenix, Arizona, United States

Veterans Affairs Medical Center - Tucson

🇺🇸

Tucson, Arizona, United States

Arizona Cancer Center at University of Arizona Health Sciences Center

🇺🇸

Tucson, Arizona, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

Veterans Affairs Medical Center - Little Rock

🇺🇸

Little Rock, Arkansas, United States

City of Hope Comprehensive Cancer Center

🇺🇸

Duarte, California, United States

Veterans Affairs Medical Center - Loma Linda (Pettis)

🇺🇸

Loma Linda, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

🇺🇸

Los Angeles, California, United States

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MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States

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