Status:
COMPLETED
The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer
Lead Sponsor:
ARCAGY/ GINECO GROUP
Conditions:
Pancreatic Neoplasms
Biliary Tract Neoplasms
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00268840
Start Date
August 1 2001
End Date
February 1 2006
Last Update
June 30 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Hôtel Dieu
Paris, France, 75004