SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer (NCT00095992) | Clinical Trial Compass
CompletedPhase 2
SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer
Canada15 participantsStarted 2005-03-08
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as SB-715992, 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 SB-715992 works in treating patients with locally advanced, recurrent, or metastatic liver cancer.
Who can participate
Age range18 Years – 120 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 hepatocellular carcinoma
* Locally advanced, recurrent, or metastatic disease
* Histologically confirmed disease must have archival paraffin-fixed tumor specimen available
* Measurable disease
* At least 1 unidimensionally measurable site of disease ≥ 20 mm by x-ray, physical exam, or non-spiral CT scan OR ≥ 10 mm by spiral CT scan
* Outside of previously irradiated area
* Patients whose sole site of disease is in a previously irradiated field are eligible provided there is evidence of disease progression OR new lesions documented in the irradiated field
* Bone metastases are not considered measurable disease
* Not curable by standard therapies
* No cholangiocarcinoma
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 80,000/mm\^3
Hepatic
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* AST ≤ 5 times ULN
* Must have hepatic reserve of Child-Turcotte-Pugh class A or better
Renal
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No myocardial infarction within the past 6 months
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No active cardiomyopathy
* No uncontrolled hypertension
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* …