Gemcitabine Hydrochloride and Oxaliplatin or Observation in Treating Patients With Biliary Tract Cancer That Has Been Removed by Surgery

NCT01313377 | Completed Phase 3

• 5 other identifiers: CDR0000696193FRE-FNCLCC-ACCORD-18/0803FRE-FNCLCC-PRODIGE-12EUDRACT-2008-004560-39EU-20982
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 37

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Observation is watching a patient's condition but not giving treatment until symptoms appear. It is not yet known whether giving gemcitabine hydrochloride together with oxaliplatin is more effective than observation in treating patients with biliary tract cancer that has been removed by surgery. PURPOSE: This randomized phase III trial is studying giving gemcitabine hydrochloride together with oxaliplatin to see how well it works compared with observation in treating patients with biliary tract cancer that has been removed by surgery.

Conditions

Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer

Keywords

adenocarcinoma of the extrahepatic bile duct; cholangiocarcinoma of the extrahepatic bile duct; liver and intrahepatic biliary tract cancer; localized extrahepatic bile duct cancer; adenocarcinoma of the gallbladder; cholangiocarcinoma of the gallbladder; localized gallbladder cancer

Outcome Measures

Primary Outcomes (2)

• Disease-free survival

  up to 3 years

• Quality of life

  up to 3 years

Secondary Outcomes (2)

• Overall survival

  up to 3 years

• Toxicity of adjuvant chemotherapy

  up to 3 years

Study Arms (2)

ARM A: Gemox 85

EXPERIMENTAL

Adjuvant chemotherapy for six months with gemcitabine - oxaliplatin 85mg / m² ( GEMOX 85)

Drug: gemcitabine hydrochloride; Drug: oxaliplatin; Procedure: adjuvant therapy; Procedure: quality-of-life assessment

ARM B:

OTHER

Observation until progression or death

Other: clinical observation; Procedure: quality-of-life assessment

Interventions

gemcitabine hydrochloride DRUG

ARM A: Gemox 85

oxaliplatin DRUG

ARM A: Gemox 85

clinical observation OTHER

ARM B:

adjuvant therapy PROCEDURE

ARM A: Gemox 85

quality-of-life assessment PROCEDURE

ARM A: Gemox 85; ARM B:

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven adenocarcinoma of the intrahepatic bile ducts, gallbladder, or extrahepatic bile ducts * Mixed forms of hepatocholangiocarcinomas included provided the cholangiocarcinoma is predominant * Underwent surgical resection of the disease (R0 or R1) at least 4 weeks but no more than 13 weeks ago * Nonmetastatic disease as assessed by abdominal MRI and chest x-ray * No cancer of the pancreas or duodenum invading the bile duct and ampulla of Vater PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Hemoglobin ≥ 10 g/dL (transfusion allowed) * ANC ≥ 1,500/mm³ * Platelet count ≥ 75,000/mm³ * Creatinine clearance \> 40 mL/min * Prothrombin time \> 60% OR INR \< 1.5 (without anticoagulant therapy) * Transaminases ≤ 5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Conjugated bilirubin ≤ 35 μmol/L (after biliary drainage, if necessary) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No contraindications to oxaliplatin and gemcitabine hydrochloride therapy * Prior invasive cancer allowed provided it has been in complete remission for ≥ 5 years * No other concurrent invasive cancer except adequately treated carcinoma in situ of the cervix or basal cell carcinoma * No other severe, unresolved disease * No mental illness * No HIV positivity * No grade 1 angina or symptomatic angina ≥ grade 2 * No sensitive peripheral neuropathy * No uncontrolled diabetes * No inability to undergo medical tests due to geographical, social, or psychological reasons * No prisoners or patients under guardianship * No Child B or C cirrhosis PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior neoadjuvant chemotherapy or radiotherapy * No prior organ transplantation * No concurrent participation in another clinical trial of an experimental agent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (37)

CHU - Hôpital Nord

Amiens, 80054, France

Location

Centre Paul Papin

Angers, 49933, France

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

Centre hospitalier de la Côte Basque

Bayonne, 64109, France

Location

Hôpital Jean Minjoz

Besançon, 25030, France

Location

Hôpital Avicenne

Bobigny, 93009, France

Location

CHU Brest - Hôpital Morvan

Brest, 29200, France

Location

CHU Côte de Nacre

Caen, 14000, France

Location

CHU Estaing

Clermont-Ferrand, 63003, France

Location

Hôpital Beaujon

Clichy, 92118, France

Location

Hôpital Henri Mondor

Créteil, 94000, France

Location

Hôpital Bocage

Dijon, 21079, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Hôpital Privé Jean Mermoz

Lyon, 69373, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

Hôpital Saint Joseph

Marseille, 13008, France

Location

Hôpital Nord

Marseille, 13015, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

CHU Timone Adulte

Marseille, 13385, France

Location

Centre Hospitalier Saint Eloi

Montpellier, 34295, France

Location

Centre René Gauducheau

Nantes, 44805, France

Location

Hôpital La Source

Orléans, 45067, France

Location

Hôpital Saint Antoine

Paris, 75012, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

CHU Saint Louis

Paris, 75475, France

Location

Hôpital de la Pitié Salpétrière

Paris, 75651, France

Location

Hôpital Européen Georges Pompidou

Paris, 75908, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

CHU de Rouen - Hôpital Ch. Nicolle

Rouen, 76031, France

Location

CHU Sainte-Etienne - Hopital Nord

Saint-Étienne-d'Orthe, 42255, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Hôpital de Hautepierre / Hôpital Civil

Strasbourg, 67098, France

Location

Hôpital Trousseau

Tours, 37044, France

Location

CHU Brabois

Vandouevre Les Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Bile Duct Neoplasms; Gallbladder Neoplasms; Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Gemcitabine; Oxaliplatin; Watchful Waiting; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Eveline Boucher, MD

  Centre Eugene Marquis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 11, 2011
• Study Start: July 1, 2009
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

FR (37)