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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Romidepsin

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