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

Primary Purpose

Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
gemcitabine hydrochloride
oxaliplatin
clinical observation
adjuvant therapy
quality-of-life assessment
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU - Hôpital Nord
  • Centre Paul Papin
  • Institut Sainte Catherine
  • Centre hospitalier de la Côte Basque
  • Hôpital Jean Minjoz
  • Hôpital Avicenne
  • CHU Brest - Hôpital Morvan
  • CHU Côte de Nacre
  • CHU Estaing
  • Hôpital Beaujon
  • Hôpital Henri Mondor
  • Hôpital Bocage
  • CHD Vendée
  • Centre Léon Bérard
  • Hôpital Privé Jean Mermoz
  • Hôpital Edouard Herriot
  • Hôpital Saint Joseph
  • Hôpital Nord
  • Institut Paoli Calmettes
  • CHU Timone Adulte
  • Centre Hospitalier Saint Eloi
  • Centre René Gauducheau
  • Hôpital La Source
  • Hôpital Saint Antoine
  • Institut Mutualiste Montsouris
  • CHU Saint Louis
  • Hôpital de la Pitié Salpétrière
  • Hôpital Européen Georges Pompidou
  • CHU de Poitiers
  • Centre Eugene Marquis
  • CHU de Rouen - Hôpital Ch. Nicolle
  • CHU Sainte-Etienne - Hopital Nord
  • Centre Paul Strauss
  • Hôpital de Hautepierre / Hôpital Civil
  • Hôpital Trousseau
  • CHU Brabois
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ARM A: Gemox 85

ARM B:

Arm Description

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

Observation until progression or death

Outcomes

Primary Outcome Measures

Disease-free survival
Quality of life

Secondary Outcome Measures

Overall survival
Toxicity of adjuvant chemotherapy

Full Information

First Posted
March 10, 2011
Last Updated
January 24, 2017
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT01313377
Brief Title
Gemcitabine Hydrochloride and Oxaliplatin or Observation in Treating Patients With Biliary Tract Cancer That Has Been Removed by Surgery
Official Title
Phase III Multicenter Randomized Study Comparing the Effect of Adjuvant Chemotherapy for Six Months With Gemcitabine-Oxaliplatin 85 mg/m2 (GEMOX 85) to Observation in Patients Who Underwent Surgery for Cancer of the Bile Ducts
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Compare disease-free survival (DFS) of patients with resected biliary tract cancer treated with adjuvant gemcitabine hydrochloride and oxaliplatin versus clinical observation. Compare quality of life of these patients. Secondary Compare overall survival of these patients. Determine the toxicity of the chemotherapy in these patients. Explore prognostic factors for DFS including resection result (R0 vs R1), location of primary tumor (intrahepatic vs extrahepatic vs gallbladder), evolution of CA19-9, and lymph node involvement (N0 vs N+ and Nx). (Exploratory) Study pathological factors in surgical specimens to identify main characteristics and phenotypic clinicoanatomical biliary tract cancers before therapy. (Exploratory) Identify nontumor-associated liver injury and factors that may facilitate the emergence of biliary tract cancers. (Exploratory) Identify signaling pathways that may predict response to therapy. (Exploratory) Determine the molecular characteristics to differentiate tumors according to their position in the biliary tract (extrahepatic bile duct, intrahepatic cholangiocarcinoma site [hilar], and peripheral cholangiocarcinoma vesicle site). (Exploratory) OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 14 days for 12 courses. Arm II: Patients undergo clinical observation only every 4 weeks for 5 months. Quality of life is assessed at baseline, at 3 and 6 months, and then at all follow-up visits. After completion of study therapy, patients are followed up at 6 months, every 3 months for 2 years, and then every 6 months for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARM A: Gemox 85
Arm Type
Experimental
Arm Description
Adjuvant chemotherapy for six months with gemcitabine - oxaliplatin 85mg / m² ( GEMOX 85)
Arm Title
ARM B:
Arm Type
Other
Arm Description
Observation until progression or death
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Type
Other
Intervention Name(s)
clinical observation
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
up to 3 years
Title
Quality of life
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
up to 3 years
Title
Toxicity of adjuvant chemotherapy
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eveline Boucher, MD
Organizational Affiliation
Centre Eugene Marquis
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU - Hôpital Nord
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Centre hospitalier de la Côte Basque
City
Bayonne
ZIP/Postal Code
64109
Country
France
Facility Name
Hôpital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
CHU Brest - Hôpital Morvan
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHU Côte de Nacre
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CHU Estaing
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Hôpital Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHD Vendée
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hôpital Privé Jean Mermoz
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Hôpital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Hôpital Nord
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
CHU Timone Adulte
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Hospitalier Saint Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre René Gauducheau
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Hôpital La Source
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHU Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hôpital de la Pitié Salpétrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
CHU de Rouen - Hôpital Ch. Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHU Sainte-Etienne - Hopital Nord
City
Sainte-Etienne
ZIP/Postal Code
42255
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Hôpital de Hautepierre / Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hôpital Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CHU Brabois
City
Vandouevre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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