Biliary Cancers: EGFR INhibitor, Gemcitabine and Oxaliplatin

NCT00552149 | Completed Phase 2 DMC

• 2 other identifiers: BINGOCSET 1287
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Biliary Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of treatment efficacy by assessing the crude progression-free survival (PFS) rate at 4 months

  4 months

Secondary Outcomes (4)

• Evaluation of feasibility and toxicity of the treatments

  one year

• Evaluation of rate and duration of objective tumor response

  one year

• Evaluation of rate and duration of tumor control (objective responses and stabilizations)

  one year

• Evaluation of PFS and over

  one year

Study Arms (2)

1

ACTIVE COMPARATOR

GEMOX

Drug: Gemox, Cetuximab

2

EXPERIMENTAL

GEMOX + CETUXIMAB

Drug: Gemox, Cetuximab

Interventions

Gemox, Cetuximab DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adenocarcinoma of the biliary tract (gallbladder, intra and/or extrahepatic bile ducts, or ampulla of Vater):
• 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,
• Age between 18 and 75 years.
• World Health Organization (WHO) performance status of 0 or 1.
• Life expectancy higher than 3 months.
• 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.
• 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.
• 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).

You may not qualify if:

• Known central nervous system metastases.
• Contraindication or history of grade 3-4 allergy reaction to one treatment component.
• 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).
• Participation in another clinical trial within 30 days prior to start of treatment.
• Concomitant systemic chronic immunotherapy, chemotherapy, or antitumor hormone therapy.
• Previous administration of EGFR inhibitors or EGF.
• 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.
• Pregnancy (or positive b-HCG dosage at baseline), breast-feeding, or lack of effective contraception in male or female pts of reproductive potential.
• 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.
• Legal incapacity or physical, psychological or mental status interfering with the pt's ability to terminate the study or to sign the informed consent.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead
• Merck Serono International SA: collaborator

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94800, France

Location

Related Publications (1)

• Malka D, Cervera P, Foulon S, Trarbach T, de la Fouchardiere C, Boucher E, Fartoux L, Faivre S, Blanc JF, Viret F, Assenat E, Seufferlein T, Herrmann T, Grenier J, Hammel P, Dollinger M, Andre T, Hahn P, Heinemann V, Rousseau V, Ducreux M, Pignon JP, Wendum D, Rosmorduc O, Greten TF; BINGO investigators. Gemcitabine and oxaliplatin with or without cetuximab in advanced biliary-tract cancer (BINGO): a randomised, open-label, non-comparative phase 2 trial. Lancet Oncol. 2014 Jul;15(8):819-28. doi: 10.1016/S1470-2045(14)70212-8. Epub 2014 May 19.

  PMID: 24852116 DERIVED

MeSH Terms

Interventions

Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• David MALKA, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 31, 2007
• First Posted: November 1, 2007
• Study Start: October 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 13, 2012

Record last verified: 2007-10

Locations

FR (1)