FR901228 in Treating Patients With Previously Treated Unresectable Locally Advanced or Metastatic… (NCT00077337) | Clinical Trial Compass
CompletedPhase 2
FR901228 in Treating Patients With Previously Treated Unresectable Locally Advanced or Metastatic Colorectal Cancer
United StatesStarted 2004-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sign…