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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: romidepsin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: romidepsin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent colon cancer, stage III colon cancer, stage IV colon cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer