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Phase II Study of FR901228 (Depsipeptide) in Patients With Previously Treated Unresectable Locally Advanced or Metastatic Colorectal Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Published Results Trial Contact Information Registry Information
Alternate Title
FR901228 in Treating Patients With Previously Treated Unresectable Locally Advanced or Metastatic Colorectal Cancer
Basic Trial Information
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Protocol IDs
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Phase II
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Treatment
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Completed
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Over 18
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NCI
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SWOG-S0336 S0336, NCT00077337
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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.
Entry 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
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
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - WBC ≥ 3,000/mm3
- Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
Hepatic - Bilirubin ≤ upper limit of normal (ULN)
- SGOT and SGPT ≤ 2.5 times ULN
Renal 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
Expected Enrollment A total of 20-40 patients will be accrued for this study within 4-10 months. 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. Published ResultsWhitehead RP, McCoy S, Wollner IS, et al.: 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: a Southwest Oncology Group study. [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-255, 2006.
Trial Contact Information
Trial Lead Organizations Southwest Oncology Group | | | Robert Whitehead, MD, Study coordinator | | | |
Registry Information | | Official Title | | 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 | | Trial Start Date | | 2004-04-19 | | Registered in ClinicalTrials.gov | | NCT00077337 | | Date Submitted to PDQ | | 2003-12-19 | | Information Last Verified | | 2005-11-01 | | NCI Grant/Contract Number | | U10-CA32102 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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