Status:
TERMINATED
Study of Sunitinib in Patients With Advanced/Inoperable Fibrolamellar Carcinoma
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hepatocellular Carcinoma
Fibrolamellar Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 t...
Detailed Description
Fibrolamellar hepatocellular carcinoma is variant rare of hepatocellular carcinoma witch distinct clinical, histological and prognostic features from conventional hepatocellular carcinoma. This entity...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01215565
Start Date
October 1 2009
End Date
May 1 2012
Last Update
March 13 2014
Active Locations (1)
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1
Hôpital Beaujon
Clichy, Hauts de Seine, France, 92110