Study of Sunitinib in Patients With Advanced/Inoperable Fibrolamellar Carcinoma

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the antitumor activity of sunitinib in patients with advanced/inoperable fibrolamellar hepatocellular carcinoma.

Rationale: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor

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

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Angiogenesis Modulating Agents; Sunitinib

Criteria

Inclusion Criteria:

• Fibrolamellar hepatocellular carcinoma histopathologically proven

• Inoperable/advanced (Tumor recurrence inoperable or metastatic with no surgical indication).

• Available Tumor tissue for analysis(biopsy or surgical specimen)

• Performance status WHO ≤ 2.

• Adequate organ function :

• Hematology (absolute neutrophil count equal or superior to 1,5 x 10*9/l , platelet equal or superior to 100 x 10*9/l),

• clearance of creatinine > 60 ml/min),

• AST/ALT ≤ 5 N, PAL ≤ 5 N, total bilirubin ≤ 2N.

Exclusion Criteria:

• Hypersensitivity to sunitinib.

• Contraindication to sunitinib, including uncontrolled hypertension, medical history of cerebrovascular accident, unstable cardiac pathology despite optimal medical therapy (myocardial infarction within the 6 months prior to study drug administration, severe/unstable angina ), active hemorrhagic syndrome or concomitant treatment with anticoagulants.

• Any severe acute or chronic co-morbid that may compromise to comply with study participation : uncontrolled infection, symptomatic congestive heart failure, liver disturbance, chronic renal failure, active gastro-duodenal ulcer (nonexhaustive list)

• Known brain metastases.

• Diagnosis of any second malignancy within the last 3 years, except for basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri

• Current treatment on another clinical trial.

• Prior treatment with an investigational agent within 4 weeks

• Patient on i.v bisphosphonate therapy