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

NCT00077337 | Completed Phase 2

• 2 other identifiers: CDR0000350199SWOG-S0336
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 88

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.

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer; stage III colon cancer; stage IV colon cancer; recurrent rectal cancer; stage III rectal cancer; stage IV rectal cancer

Interventions

romidepsin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed colorectal cancer meeting 1 of the following criteria: * Locally advanced unresectable disease * Distant metastatic disease * Measurable disease * Previously treated with at least 1, but no more than 2, prior chemotherapy regimens for unresectable locally advanced or metastatic disease * May have included irinotecan or oxaliplatin * No more than 1 prior chemotherapy regimen (not oxaliplatin-based) for advanced or metastatic disease if previously treated with oxaliplatin-based adjuvant chemotherapy * No more than 1 prior chemotherapy regimen (not irinotecan-based) for advanced or metastatic disease if previously treated with irinotecan-based adjuvant chemotherapy * No known brain metastases PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ upper limit of normal (ULN) * SGOT and SGPT ≤ 2.5 times ULN Renal * Creatinine ≤ ULN Cardiovascular * No New York Heart Association class III or IV congestive heart failure * No myocardial infarction within the past year * No uncontrolled dysrhythmias * No poorly controlled angina * No prior serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) * No left ventricular hypertrophy * QTc \< 500 msec * No other significant cardiac disease Other * Not pregnant or nursing * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No prior allergic reaction attributed to compounds of similar chemical or biological composition to FR901228 PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent anticancer immunotherapy Chemotherapy * See Disease Characteristics * At least 28 days since prior chemotherapy and recovered * No prior FR901228 (depsipeptide) * No other concurrent anticancer chemotherapy Endocrine therapy * No concurrent anticancer hormonal therapy Radiotherapy * At least 28 days since prior radiotherapy and recovered * No concurrent anticancer radiotherapy Surgery * At least 28 days since prior surgery and recovered Other * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent agent that causes QTc prolongation * No concurrent hydrochlorothiazide * No other concurrent investigational agents * No other concurrent drugs that have histone deacetylase inhibitor activity (e.g., valproic acid) * No other concurrent anticancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (88)

MBCCOP - Gulf Coast

Mobile, Alabama, 36607, United States

Location

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

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

Phoenix, Arizona, 85012, United States

Location

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, 85723, United States

Location

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Veterans Affairs Medical Center - Little Rock

Little Rock, Arkansas, 72205, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Veterans Affairs Medical Center - Loma Linda (Pettis)

Loma Linda, California, 92357, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Veterans Affairs Outpatient Clinic - Martinez

Martinez, California, 94553, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

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

Orange, California, 92868, United States

Location

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

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

Aurora, Colorado, 80010, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

MBCCOP - Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

Veterans Affairs Medical Center - Tampa (Haley)

Tampa, Florida, 33612, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Veterans Affairs Medical Center - Chicago Westside Hospital

Chicago, Illinois, 60612, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

Veterans Affairs Medical Center - Hines

Hines, Illinois, 60141, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153-5500, United States

Location

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

Kansas City, Kansas, 66160-7353, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Veterans Affairs Medical Center - Wichita

Wichita, Kansas, 67218, United States

Location

Veterans Affairs Medical Center - Lexington

Lexington, Kentucky, 40502-2236, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0084, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Tulane Cancer Center at Tulane University Hospital and Clinic

New Orleans, Louisiana, 70112, United States

Location

Veterans Affairs Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Veterans Affairs Medical Center - Shreveport

Shreveport, Louisiana, 71101-4295, United States

Location

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, 71130-3932, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0948, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Veterans Affairs Medical Center - Detroit

Detroit, Michigan, 48201-1932, United States

Location

Josephine Ford Cancer Center at Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Beaumont

Royal Oak, Michigan, 48073-6769, United States

Location

Providence Cancer Institute at Providence Hospital - Southfield Campus

Southfield, Michigan, 48075, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Veterans Affairs Medical Center - Jackson

Jackson, Mississippi, 39216, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

Saint Louis University Cancer Center

St Louis, Missouri, 63110, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Veterans Affairs Medical Center - Albuquerque

Albuquerque, New Mexico, 87108-5138, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

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

Rochester, New York, 14642, United States

Location

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479, United States

Location

Veterans Affairs Medical Center - Cincinnati

Cincinnati, Ohio, 45220-2288, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0501, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195-9001, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428-1002, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97201-3098, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Veterans Affairs Medical Center - Charleston

Charleston, South Carolina, 29401-5799, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

University of Tennessee Cancer Institute at Methodist Central Hospital

Memphis, Tennessee, 38104, United States

Location

Veterans Affairs Medical Center - Memphis

Memphis, Tennessee, 38104, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Veterans Affairs Medical Center - Amarillo

Amarillo, Texas, 79106, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234-6200, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0565, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4095, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Veterans Affairs Medical Center - Temple

Temple, Texas, 76504, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112-5550, United States

Location

Veterans Affairs Medical Center - Salt Lake City

Salt Lake City, Utah, 84148, United States

Location

Sentara Cancer Institute at Sentara Norfolk General Hospital

Norfolk, Virginia, 23510-1115, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Veterans Affairs Medical Center - Seattle

Seattle, Washington, 98108, United States

Location

Puget Sound Oncology Consortium

Seattle, Washington, 98109, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

Related Publications (2)

• Whitehead RP, Rankin C, Hoff PM, Gold PJ, Billingsley KG, Chapman RA, Wong L, Ward JH, Abbruzzese JL, Blanke CD. Phase II trial of romidepsin (NSC-630176) in previously treated colorectal cancer patients with advanced disease: a Southwest Oncology Group study (S0336). Invest New Drugs. 2009 Oct;27(5):469-75. doi: 10.1007/s10637-008-9190-8. Epub 2008 Oct 22.

  PMID: 18941712 RESULT

• Whitehead RP, McCoy S, Wollner IS, et al.: Phase II trial of depsipeptide (NSC-630176) in colorectal cancer patients who have received either one or two prior chemotherapy regimens for metastatic or locally advanced, unresectable disease: a Southwest Oncology Group study. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-255, 2006.

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Robert P. Whitehead, MD

  University of Texas

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 12, 2004
• Study Start: April 1, 2004
• Study Completion: April 1, 2006
• Last Updated: June 24, 2013

Record last verified: 2005-11

Locations

US (88)