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
Phase 2
18 Years
60 Years
18 Years
60 Years
Not Enrolling
Both
Pancreatic Neoplasms, Biliary Tract Neoplasms
Both
Pancreatic Neoplasms, Biliary Tract Neoplasms
Trial Information
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
Try a new drug association on this advanced cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate
Principal Investigator
Chauvenet Laure, MD
Investigator Role:
Study Chair
Investigator Affiliation:
ARCAGY/ GINECO GROUP
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
RIO PANCREAS
NCT ID:
NCT00268840
Start Date:
August 2001
Completion Date:
February 2006
Related Keywords:
- Pancreatic Neoplasms
- Biliary Tract Neoplasms
- Pancreas or biliary cancer
- Biliary Tract Neoplasms
- Neoplasms
- Pancreatic Neoplasms
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