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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00077337
Enrollment
Unknown
Registered
2004-02-12
Start date
2004-04-30
Completion date
2006-04-30
Last updated
2013-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer, stage III colon cancer, stage IV colon cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer

Brief 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.

Detailed description

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.

Interventions

DRUGromidepsin

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
SWOG Cancer Research Network
Lead SponsorNETWORK

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026