SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer

• Status: Completed
• Trial end date: 2008-09-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Collaborator: National Cancer Institute (NCI)

Criteria

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

• No clinical evidence of encephalopathy

• No ongoing or active infection

• No history of allergic reaction attributed to compounds of similar chemical or biological composition to SB-715992

• No psychiatric illness or social situation that would preclude study compliance

• No other uncontrolled illness

• No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 4 weeks since prior intra-hepatic chemotherapy as a component of trans-arterial chemoembolization and recovered

• Documented disease progression

• No prior systemic chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

• Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy

Surgery

• At least 4 weeks since prior major surgery

• Prior liver transplantation allowed

Other

• No other prior systemic therapy

• At least 4 weeks since prior local ablative therapy (e.g., radiofrequency ablation or ethanol injection) and recovered

• Documented disease progression

• More than 28 days since prior investigational agents

• More than 14 days since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers:

• Clarithromycin

• Erythromycin

• Troleandomycin

• Itraconazole

• Ketoconazole

• Fluconazole (dose > 200 mg/day)

• Voriconazole

• Nefazodone

• Fluvoxamine

• Verapamil

• Diltiazem

• Grapefruit juice

• Bitter orange

• Phenytoin

• Carbamazepine

• Phenobarbital

• Oxcarbazepine

• Rifampin

• Rifabutin

• Rifapentine

• Hypericum perforatum (St. John's wort)

• Modafinil

• At least 6 months since prior and no concurrent amiodarone

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent anticancer therapy

• No other concurrent investigational agents