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Status:

COMPLETED

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

Lead Sponsor:

SWOG Cancer Research Network

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 FR9012...

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 (depsipep...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    April 1 2006

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00077337

    Start Date

    April 1 2004

    End Date

    April 1 2006

    Last Update

    June 24 2013

    Active Locations (88)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 22 (88 locations)

    1

    MBCCOP - Gulf Coast

    Mobile, Alabama, United States, 36607

    2

    CCOP - Western Regional, Arizona

    Phoenix, Arizona, United States, 85006-2726

    3

    Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

    Phoenix, Arizona, United States, 85012

    4

    Veterans Affairs Medical Center - Tucson

    Tucson, Arizona, United States, 85723