Completed

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

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What is being tested

romidepsin

Drug
Who is being recruted

Colorectal Cancer

Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2004

Summary

Principal SponsorSWOG Cancer Research Network
Last updated: June 24, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitlePhase 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 
Principal SponsorSWOG Cancer Research Network
Last updated: June 24, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colorectal Cancer
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 88 locations
Suspended
MBCCOP - Gulf CoastMobile, United StatesSee the location
Suspended
CCOP - Western Regional, ArizonaPhoenix, United States
Suspended
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, United States
Suspended
Veterans Affairs Medical Center - TucsonTucson, United States

Completed88 Study Centers