The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer
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
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2001
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
December 22, 2005
CompletedFirst Posted
Study publicly available on registry
December 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedJune 30, 2011
June 1, 2011
4.5 years
December 22, 2005
June 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate
Secondary Outcomes (4)
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
Study Arms (1)
unique
EXPERIMENTALTaxotère - Gemzar
Interventions
Docetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Hôtel Dieu
Paris, 75004, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chauvenet Laure, MD
ARCAGY/ GINECO GROUP
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 22, 2005
First Posted
December 23, 2005
Study Start
August 1, 2001
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
June 30, 2011
Record last verified: 2011-06