Study of Sunitinib in Patients With Advanced/Inoperable Fibrolamellar Carcinoma

NCT01215565 | Terminated Phase 2 DMC

• 2 other identifiers: P0701342008-003423-23
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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 tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor

Conditions

Hepatocellular Carcinoma; Fibrolamellar Hepatocellular Carcinoma

Keywords

Carcinoma, Hepatocellular; Carcinoma; Fibrosis; Liver Neoplasms; Pathologic Processes; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Liver Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Sunitinib; Antineoplastic Agents; Therapeutic Uses; Pharmacologic Actions; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors

Outcome Measures

Primary Outcomes (1)

• Objective response

  to evaluate the objective response according to RECIST Criteria 1.1

  1 year

Secondary Outcomes (5)

• Objective response

  1 year

• Overall survival

  6 months and 1 year

• Progression-Free survival

  6 months and 1 year

• Biomarkers of response

  1 year

• Biomarkers of radiological response

  1 year

Study Arms (1)

patient treated

EXPERIMENTAL

patient who receive sunitinib

Drug: Sutent

Interventions

Sutent DRUG

Sunitinib 50mg/day (per os) for 6 cycles duration of one cycle = 6 weeks (4 weeks of treatment over 6 weeks)

patient treated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Beaujon

Clichy, Hauts de Seine, 92110, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Fibrolamellar hepatocellular carcinoma; Carcinoma; Fibrosis; Liver Neoplasms; Pathologic Processes; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Liver Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sandrine Faivre, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: October 6, 2010
• Study Start: October 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2012
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

FR (1)