NCT00077337
FR901228 in Treating Patients With Previously Treated Unresectable Locally Advanced or Metastatic Colorectal Cancer
PHASE2
COMPLETED
NCT00077337
INTERVENTIONAL
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
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.
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
Colorectal Cancer
- TREATMENT
-
- Type: DRUG
- Name: romidepsin
- Description:
- Arm Group Labels:
- SWOG Cancer Research Network