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

Date de début de l'étude : 1 avril 2004

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