Clinical trial NCT00077337 (phase 2, status: completed)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: romidepsin
SMILES: C\C=C1/NC(=O)[C@H]2CSSCC\C=C\[C@H](CC(=O)N[C@H](C(C)C)C(=O)N2)OC(=O)[C@@H](NC1=O)C(C)C
Eligibility criteria:

        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