A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine – Oxaliplatin Chemotherapy Alone or in Combination with Cetuximab in Patients with Advanced Biliary Cancer - BINGO

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 100

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 < 1.5 (following vitamin K1 injection in pts with current or recent history of jaundice or bile duct obstruction), creatinine = 1.5 ULN, neutrophils = 1.5 10^9/L, platelets = 100 10^9/L, hemoglobin = 9 g/dL (red blood cell transfusion if needed is allowed).
8.Written informed consent.
Note: EGFR tumor status has to be known for every patient, but it is neither an inclusion/exclusion criterion nor a stratification factor. EGFR expression has to be assessed by Immunohistochemistry using biopsy or surgical material, at any time prior to inclusion into the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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