Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well temsirolimus works in treating patients with advanced liver cancer and cirrhosis.

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

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Treatments: Everolimus; Sirolimus

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of the Liver (EASL) criteria

• Advanced disease

• Must be morphologically evaluable

• HCC not accessible to other treatment (e.g., surgery, radiofrequency, or chemoembolization) and can not benefit from antiangiogenic therapy

• CLIP score ≤ 3 (except for patients with tumors invading more than 50% of tumor volume)

• Child-Pugh cirrhosis score between B7 and B9, meeting the following criteria:

• Diagnosed clinically, biologically (e.g., prothrombin time, platelets, or albumin), endoscopically (signs of portal hypertension) and morphologically (dysmorphic liver on ultrasound or CT scan), or by liver biopsy

• Not a candidate for transplantation and has not received a liver transplant

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy ≥ 3 months

• Platelet count ≥ 50,000/mm^3

• Neutrophil count ≥ 1,500/mm^3

• Creatinine clearance ≥ 60 mL/min

• GFR ≥ 30 mL/min

• Serum cholesterol ≤ 350 mg/dL

• Triglycerides ≤ 300 mg/dL

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for more than 2 months after completion of study therapy

• No history of other cancer on treatment

• No cardiopulmonary disease impairment, including a history of stable or unstable angina or myocardial infarction

• No active infection except for viral hepatitis

• No HIV positivity

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 2 weeks since prior inhibitors or inducers of P-glycoprotein, CYP3A4, or CYP3A5

• At least 4 weeks since prior surgery, radiotherapy (except radiotherapy to the bone), transarterial chemoembolization, immunotherapy, or other investigational drug for HCC

• At least 6 months since prior chemotherapy