MedPath

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)

USC/Norris Comprehensive Cancer Center and Hospital

🇺🇸

Los Angeles, California, United States

Jonsson Comprehensive Cancer Center at UCLA

🇺🇸

Los Angeles, California, United States

CCOP - Atlanta Regional

🇺🇸

Atlanta, Georgia, United States

Veterans Affairs Medical Center - Chicago Westside Hospital

🇺🇸

Chicago, Illinois, United States

Providence Cancer Institute at Providence Hospital - Southfield Campus

🇺🇸

Southfield, Michigan, United States

M.D. Anderson Cancer Center at University of Texas

🇺🇸

Houston, Texas, United States

CCOP - Virginia Mason Research Center

🇺🇸

Seattle, Washington, United States

Veterans Affairs Medical Center - Seattle

🇺🇸

Seattle, Washington, United States

Puget Sound Oncology Consortium

🇺🇸

Seattle, Washington, United States

Veterans Affairs Medical Center - Cincinnati

🇺🇸

Cincinnati, Ohio, United States

Charles M. Barrett Cancer Center at University Hospital

🇺🇸

Cincinnati, Ohio, United States

University of Texas Health Science Center at San Antonio

🇺🇸

San Antonio, Texas, United States

Huntsman Cancer Institute at University of Utah

🇺🇸

Salt Lake City, Utah, United States

CCOP - Wichita

🇺🇸

Wichita, Kansas, United States

Veterans Affairs Medical Center - Wichita

🇺🇸

Wichita, Kansas, United States

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

🇺🇸

Kansas City, Kansas, United States

University of Mississippi Medical Center

🇺🇸

Jackson, Mississippi, United States

MBCCOP - University of Illinois at Chicago

🇺🇸

Chicago, Illinois, United States

MBCCOP - LSU Health Sciences Center

🇺🇸

New Orleans, Louisiana, United States

Veterans Affairs Medical Center - Hines

🇺🇸

Hines, Illinois, United States

CCOP - Beaumont

🇺🇸

Royal Oak, Michigan, United States

Veterans Affairs Medical Center - Lexington

🇺🇸

Lexington, Kentucky, United States

Tulane Cancer Center at Tulane University Hospital and Clinic

🇺🇸

New Orleans, Louisiana, United States

CCOP - Dayton

🇺🇸

Dayton, Ohio, United States

Veterans Affairs Medical Center - Jackson

🇺🇸

Jackson, Mississippi, United States

CCOP - Bay Area Tumor Institute

🇺🇸

Oakland, California, United States

CCOP - Southeast Cancer Control Consortium

🇺🇸

Goldsboro, North Carolina, United States

Cancer Research Center at Boston Medical Center

🇺🇸

Boston, Massachusetts, United States

MBCCOP - Hawaii

🇺🇸

Honolulu, Hawaii, United States

Markey Cancer Center at University of Kentucky Chandler Medical Center

🇺🇸

Lexington, Kentucky, United States

Veterans Affairs Medical Center - New Orleans

🇺🇸

New Orleans, Louisiana, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center

🇺🇸

Maywood, Illinois, United States

Saint Louis University Cancer Center

🇺🇸

Saint Louis, Missouri, United States

MBCCOP - University of New Mexico HSC

🇺🇸

Albuquerque, New Mexico, United States

Veterans Affairs Medical Center - Dayton

🇺🇸

Dayton, Ohio, United States

Veterans Affairs Medical Center - Loma Linda (Pettis)

🇺🇸

Loma Linda, California, United States

Hollings Cancer Center at Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

🇺🇸

Shreveport, Louisiana, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

🇺🇸

Orange, California, United States

Herbert Irving Comprehensive Cancer Center at Columbia University

🇺🇸

New York, New York, United States

Sentara Cancer Institute at Sentara Norfolk General Hospital

🇺🇸

Norfolk, Virginia, United States

CCOP - Central Illinois

🇺🇸

Decatur, Illinois, United States

Veterans Affairs Medical Center - Shreveport

🇺🇸

Shreveport, Louisiana, United States

CCOP - Columbus

🇺🇸

Columbus, Ohio, United States

CCOP - Kansas City

🇺🇸

Kansas City, Missouri, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center

🇺🇸

Rochester, New York, United States

University of Tennessee Cancer Institute at Methodist Central Hospital

🇺🇸

Memphis, Tennessee, United States

CCOP - Upstate Carolina

🇺🇸

Spartanburg, South Carolina, United States

Veterans Affairs Medical Center - Charleston

🇺🇸

Charleston, South Carolina, United States

CCOP - Grand Rapids

🇺🇸

Grand Rapids, Michigan, United States

CCOP - Scott and White Hospital

🇺🇸

Temple, Texas, United States

Brooke Army Medical Center

🇺🇸

Fort Sam Houston, Texas, United States

CCOP - Cancer Research for the Ozarks

🇺🇸

Springfield, Missouri, United States

Veterans Affairs Medical Center - Albuquerque

🇺🇸

Albuquerque, New Mexico, United States

Cleveland Clinic Taussig Cancer Center

🇺🇸

Cleveland, Ohio, United States

Veterans Affairs Medical Center - Salt Lake City

🇺🇸

Salt Lake City, Utah, United States

NYU Cancer Institute at New York University Medical Center

🇺🇸

New York, New York, United States

CCOP - Greenville

🇺🇸

Greenville, South Carolina, United States

Harrington Cancer Center

🇺🇸

Amarillo, Texas, United States

University of Texas Medical Branch

🇺🇸

Galveston, Texas, United States

Veterans Affairs Medical Center - Memphis

🇺🇸

Memphis, Tennessee, United States

Veterans Affairs Medical Center - Amarillo

🇺🇸

Amarillo, Texas, United States

Veterans Affairs Medical Center - Temple

🇺🇸

Temple, Texas, United States

CCOP - Northwest

🇺🇸

Tacoma, Washington, United States

MBCCOP - Gulf Coast

🇺🇸

Mobile, Alabama, 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

City of Hope Comprehensive Cancer Center

🇺🇸

Duarte, California, United States

Veterans Affairs Medical Center - Little Rock

🇺🇸

Little Rock, Arkansas, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

CCOP - Santa Rosa Memorial Hospital

🇺🇸

Santa Rosa, California, United States

Veterans Affairs Outpatient Clinic - Martinez

🇺🇸

Martinez, California, United States

MBCCOP - Howard University Cancer Center

🇺🇸

Washington, District of Columbia, United States

CCOP - Montana Cancer Consortium

🇺🇸

Billings, Montana, United States

CCOP - St. Louis-Cape Girardeau

🇺🇸

Saint Louis, Missouri, United States

CCOP - Western Regional, Arizona

🇺🇸

Phoenix, Arizona, United States

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

🇺🇸

Phoenix, Arizona, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center

🇺🇸

Aurora, Colorado, United States

Veterans Affairs Medical Center - Denver

🇺🇸

Denver, Colorado, United States

Veterans Affairs Medical Center - Tampa (Haley)

🇺🇸

Tampa, Florida, United States

CCOP - Michigan Cancer Research Consortium

🇺🇸

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute

🇺🇸

Detroit, Michigan, United States

Josephine Ford Cancer Center at Henry Ford Health System

🇺🇸

Detroit, Michigan, United States

University of Michigan Comprehensive Cancer Center

🇺🇸

Ann Arbor, Michigan, United States

Veterans Affairs Medical Center - Detroit

🇺🇸

Detroit, Michigan, United States

Oklahoma University Medical Center

🇺🇸

Oklahoma City, Oklahoma, United States

Cancer Institute at Oregon Health and Science University

🇺🇸

Portland, Oregon, United States

CCOP - Columbia River Oncology Program

🇺🇸

Portland, Oregon, United States

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