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FR901228 in Treating Patients With Previously Treated Unresectable Locally Advanced or Metastatic Colorectal Cancer
This study has been completed.
Study NCT00077337   Information provided by National Cancer Institute (NCI)
First Received: February 10, 2004   Last Updated: October 25, 2008   History of Changes

February 10, 2004
October 25, 2008
April 2004
 
 
 
Complete list of historical versions of study NCT00077337 on ClinicalTrials.gov Archive Site
 
 
 
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

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.

Phase II
Interventional
Treatment, Open Label
Colorectal Cancer
Drug: romidepsin
 
Whitehead RP, Rankin C, Hoff PM, Gold PJ, Billingsley KG, Chapman RA, Wong L, Ward JH, Abbruzzese JL, Blanke CD. Phase II trial of romidepsin (NSC-630176) in previously treated colorectal cancer patients with advanced disease: a Southwest Oncology Group study (S0336). Invest New Drugs. 2008 Oct 22; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00077337
 
CDR0000350199, SWOG-S0336
Southwest Oncology Group
National Cancer Institute (NCI)
Investigator: Robert P. Whitehead, MD University of Texas
National Cancer Institute (NCI)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP