Back to resultsThe Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer
Primary Purpose
Pancreatic Neoplasms, Biliary Tract Neoplasms
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Docetaxel
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Pancreas or biliary cancer
Eligibility Criteria
Inclusion Criteria: Patients aged 18 years or older Patients must sign informed consent prior to study entry Patients has Karnofsky performance status of more than 50% No prior chemotherapy Histologically or cytologically confirmed adenocarcinoma of the pancreas, locally advanced or metastatic disease or biliary cancer No previous radiotherapy for locally advanced or metastases. Hematopoietic: WBC > 3000/mm2, Absolute neutrophile count > 1500/mm2, Hemoglobin > 9g/dl, Platelet count > 100 000/mm2 Exclusion Criteria: No intracerebral or meningeal metastases Pregnant Fertile patient must use effective contraception No other serious medical condition or illness that would preclude study participation Hepatic: Bilirubin greater than upper limit of normal(ULN) SGOT and SGPT > 3.5 times upper limit of normal(ULN) alkaline phosphatase > 6 times upper limit of normal(ULN) More than 30 days since prior investigational therapy
Sites / Locations
- Hôpital Hôtel Dieu
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
unique
Arm Description
Taxotère - Gemzar
Outcomes
Primary Outcome Measures
Overall response rate
Secondary Outcome Measures
Clinical benefit
Progression-free survival
Overall survival
To evaluate the frequency and severity of the adverse events related to the combination of gemcitabine and docetaxel
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00268840
Brief Title
The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer
Official Title
National Trial Phase II to Study the Combination of Gemcitabine and Docetaxel in Patients With Locally Advanced or Metastatic Pancreatic or Biliary Adenocarcinoma That Cannot be Removed by Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
ARCAGY/ GINECO GROUP
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy of combination therapy with gemcitabine and docetaxelin in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma.
Detailed Description
Try a new drug association on this advanced cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms, Biliary Tract Neoplasms
Keywords
Pancreas or biliary cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
unique
Arm Type
Experimental
Arm Description
Taxotère - Gemzar
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
TAXOTERE
Intervention Description
Docetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
GEMZAR
Intervention Description
Gemcitabine 1200 mg/m2 à J1 et J15 toutes les 4 semaines
Primary Outcome Measure Information:
Title
Overall response rate
Secondary Outcome Measure Information:
Title
Clinical benefit
Title
Progression-free survival
Title
Overall survival
Title
To evaluate the frequency and severity of the adverse events related to the combination of gemcitabine and docetaxel
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18 years or older
Patients must sign informed consent prior to study entry
Patients has Karnofsky performance status of more than 50%
No prior chemotherapy
Histologically or cytologically confirmed adenocarcinoma of the pancreas, locally advanced or metastatic disease or biliary cancer
No previous radiotherapy for locally advanced or metastases.
Hematopoietic: WBC > 3000/mm2, Absolute neutrophile count > 1500/mm2, Hemoglobin > 9g/dl, Platelet count > 100 000/mm2
Exclusion Criteria:
No intracerebral or meningeal metastases
Pregnant
Fertile patient must use effective contraception
No other serious medical condition or illness that would preclude study participation
Hepatic: Bilirubin greater than upper limit of normal(ULN) SGOT and SGPT > 3.5 times upper limit of normal(ULN) alkaline phosphatase > 6 times upper limit of normal(ULN)
More than 30 days since prior investigational therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chauvenet Laure, MD
Organizational Affiliation
ARCAGY/ GINECO GROUP
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Hôtel Dieu
City
Paris
ZIP/Postal Code
75004
Country
France
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer
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