The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer

Phase 2

Completed

• Conditions: Pancreatic Neoplasms; Biliary Tract Neoplasms
• Interventions: Drug: Docetaxel; Drug: Gemcitabine

• Registration Number: NCT00268840
• Lead Sponsor: ARCAGY/ GINECO GROUP

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

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2005-12-22
• Study First Submitted QC: 2005-12-22
• Study First Posted: 2005-12-23
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-29
• Last Update Posted: 2011-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
unique	Docetaxel	Taxotère - Gemzar
unique	Gemcitabine	Taxotère - Gemzar

Primary Outcome Measures

Name	Time	Method
Overall response rate

Secondary Outcome Measures

Name	Time	Method
Overall survival
Clinical benefit
Progression-free survival
To evaluate the frequency and severity of the adverse events related to the combination of gemcitabine and docetaxel

Trial Locations

Locations (1)

Hôpital Hôtel Dieu; 🇫🇷 Paris, France