Biliary Cancers: EGFR INhibitor, Gemcitabine and Oxaliplatin

This study has been completed.
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00552149
First received: October 31, 2007
Last updated: June 12, 2012
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Advanced Biliary Cancer
Drug: Gemox, Cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Evaluation of treatment efficacy by assessing the crude progression-free survival (PFS) rate at 4 months [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Evaluation of feasibility and toxicity of the treatments [ Time Frame: one year ]
  • Evaluation of rate and duration of objective tumor response [ Time Frame: one year ]
  • Evaluation of rate and duration of tumor control (objective responses and stabilizations) [ Time Frame: one year ]
  • Evaluation of PFS and over [ Time Frame: one year ]

Enrollment: 150
Study Start Date: October 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
GEMOX
Drug: Gemox, Cetuximab

GEMOX (Arms 1 and 2), every two weeks:

Day 1: gemcitabine 1000 mg/m² intravenous (IV) infusion over 100 minutes (10 mg/m²/min) Day 2: oxaliplatin 100 mg/m² IV infusion over 2 h

Cetuximab (ErbituxÒ) (Arm B only) every two weeks:

(chemotherapy will be started one hour after the end of the cetuximab infusion).

Day 1 or Day 2: 500 mg/m² IV infusion over 150 minutes

Experimental: 2
GEMOX + CETUXIMAB
Drug: Gemox, Cetuximab

GEMOX (Arms 1 and 2), every two weeks:

Day 1: gemcitabine 1000 mg/m² intravenous (IV) infusion over 100 minutes (10 mg/m²/min) Day 2: oxaliplatin 100 mg/m² IV infusion over 2 h

Cetuximab (ErbituxÒ) (Arm B only) every two weeks:

(chemotherapy will be started one hour after the end of the cetuximab infusion).

Day 1 or Day 2: 500 mg/m² IV infusion over 150 minutes


Detailed Description:

The BINGO trial is an open-label randomized phase II study evaluating the efficacy and tolerance of gemcitabine-oxaliplatin combination chemotherapy (GEMOX regimen) alone or in combination with cetuximab in patients (pts) with ABC. The BINGO study also comprises ancillary translational research and functional imaging studies which aim to identify markers predictive for treatment efficacy in ABC.

All eligible pts will be randomized 1:1 to receive:

  • Arm A: GEMOX alone every two weeks.
  • Arm B: GEMOX + cetuximab every two weeks.

Randomization will be stratified according to:

  1. tumor stage (locally advanced vs metastatic),
  2. primary tumor location (gallbladder vs non-gallbladder),
  3. prior treatments (surgery or radiotherapy or brachytherapy or photodynamic therapy [PDT] or adjuvant chemotherapy vs none),
  4. center. EGFR tumor status has to be assessed for every pt by immunohistochemistry (IHC) using biopsy or surgical material, at any time prior to inclusion into the study, but it is neither an inclusion/exclusion criterion nor a stratification factor.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 FDG-PET if possible) is negative; and ii) histological examination is consistent with bile duct adenocarcinoma (IHC 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-PDT-treated area (longest diameter 1 cm [spiral CT 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 PDT 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 patients with current or recent history of jaundice or bile duct obstruction), creatinine 1.5 ULN, neutrophils 1.5 109/L, platelets 100 109/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 pt, but it is neither an inclusion/exclusion criterion nor a stratification factor. EGFR expression has to be assessed by IHC using biopsy or surgical material, at any time prior to inclusion into the study.

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 PDT 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 b-HCG dosage at baseline), breast-feeding, or lack of effective contraception in male or female pts 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 pt's ability to terminate the study or to sign the informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552149

Locations
France
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Merck Serono International SA
Investigators
Study Chair: David MALKA, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided by Gustave Roussy, Cancer Campus, Grand Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT00552149     History of Changes
Other Study ID Numbers: BINGO, CSET 1287
Study First Received: October 31, 2007
Last Updated: June 12, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms
Neoplasms by Site
Cetuximab
Gemcitabine
Oxaliplatin
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014