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Little Rock, Arkansas 72205

  • Colorectal Cancer


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.

Study summary:

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.


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

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

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

Official Title:

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

Overall Status:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:Robert P. Whitehead, MD
University of Texas

Study Dates

Start Date:April 2004
Completion Date:April 2006
Completion Type:Actual
Verification Date:November 2005
Last Changed Date:June 21, 2013
First Received Date:February 10, 2004

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Southwest Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
Reference Type:Results Reference
Citation: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. 2008 Oct 22; [Epub ahead of print]

Data Source:

Date Processed: March 30, 2020

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