adenocarcinoma of the biliary tract ( gallbladder, intra and/ or extrahepatic bile ducts, ampulla of Vater)
Conditions
Interventions
Trade Name: erbitux 5mg/ml
Product Name: Cetuximab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: cetuximab
Current Sponsor code: EMD271786
Other descriptive name: cetuximab
Concentra
Sponsors
Institut Gustave Roussy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Adenocarcinoma of the biliary tract (gallbladder, intra and/or extrahepatic bile ducts, or ampulla of Vater):· Cytologically or histologically confirmed. In case of uncertain biliary tract origin (e.g., intrahepatic, peripheral cholangiocarcinomas), inclusion is possible if i) extensive search for primary (thoracic and abdominopelvic CT scan, colonoscopy, upper digestive endoscopy, serum PSA level for men or mammography for women, and Fluorodesoxyglucose-Positron Emission Tomography if possible) is negative; and ii) histological examination is consistent with bile duct adenocarcinoma (Imunohistochemistry should ideally be performed and be consistent with biliary primary, e.g., positive for cytokeratin 7 and 19 and negative for cytokeratin 20).· - Not amenable to curative resection, or recurrent after resection (i.e., locally advanced or metastatic),· - With at least one unidimensionally measurable target lesion in a non-irradiated, non-PhotoDynamic Therapy-treated area (longest diameter =1 cm [spiral Computed Tomography scan]) or =2 cm [conventional CT scan]),· With biliary obstruction controlled, 2.Age between 18 and 75 years. 3.World Health Organization (WHO) performance status of 0 or 1. 4.Life expectancy higher than 3 months. 5.No prior chemotherapy for advanced disease. Previous adjuvant chemotherapy is allowed (completed at least = 6 months previously, if containing gemcitabine or platinum salts). Previous irradiation (external radiotherapy, brachytherapy) and Photo Dynamic Therapy are allowed provided that there is at least one unidimensionally measurable target lesion in untreated area. 6.Bilirubin = 3 times the upper limit of the normal range (ULN). Pts with jaundice or evidence of bile duct obstruction, in whom the biliary tree can be decompressed by endoscopic or percutaneous endoprothesis with subsequent reduction in bilirubin = 3 ULN, will be eligible for the study. 7. Aminotransferases (AST, ALT) = 5 ULN, INR =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Known central nervous system metastases. 2.Contraindication or history of grade 3-4 allergy reaction to one treatment component. 3.Surgery (except diagnostic biopsy), external radiotherapy, brachytherapy, or Photodynamix Therapy within 30 days prior to start of treatment. Prior adjuvant chemotherapy is only allowed if completed at least 30 days previously (6 months if containing gemcitabine or platinum salts). 4.Participation in another clinical trial within 30 days prior to start of treatment. 5.Concomitant systemic chronic immunotherapy, chemotherapy, or antitumor hormone therapy. 6.Previous administration of EGFR inhibitors or EGF. 7.Active uncontrolled infection, peripheral neuropathy = grade 2, acute or subacute bowel obstruction or history of inflammatory bowel disease, symptomatic coronary disease or myocardial infarction in the past 6 months, congestive heart failure (= NYHA class II), interstitial pneumonitis or respiratory failure, or renal failure. 8.Pregnancy (or positive bêta-HCG dosage at baseline), breast-feeding, or lack of effective contraception in male or female patients of reproductive potential. 9.Other malignancies either currently active or in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma. 10.Legal incapacity or physical, psychological or mental status interfering with the patients ability to terminate the study or to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of treatment efficacy by assessing the crude progression-free survival (PFS) rate at 4 months;Secondary Objective: 1.Toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 3.0) and to the Levi’s specific scale for peripheral neuropathy. 2.Objective tumor response rate (RECIST). 3.Disease control rate (RECIST). 4.PFS and OS. CRITERIA FOR EXPLORATORY ANALYSES: 5.Early metabolic tumor response (DSUVmax on FDG-PET within 4 weeks before the beginning of the treatment and repeated at 4 weeks) will be correlated to therapeutic response (assessed by CT scan at 2, 4 and 6 months), OS and PFS. 6.Predictive value of cetuximab-induced skin reactions (i.e., occurrence and severity) on treatment efficacy. 7.Functional or molecular alterations of EGFR pathway, predictive of the tumor response (or absence of response) to cetuximab in ABC, including detection of EGFR and KRAS mutations, detection of EGFR and HER2 gene amplification, tumor expression of EGFR, IGF-1R, HER2, HER3, phospho-Akt, detection of truncated HER2 and EGFR in serum.;Primary end point(s): PRIMARY CRITERION: crude Progression-Free Survival rate at 4 months according to RECIST (Response Evaluation Criteria in Solid Tumors). | — |
Countries
France, Germany
Outcome results
None listed