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

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.

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