The Efficacy And Safety Of Gemcitabine In Combination With Docetaxel To Treat Pancreatic Or Biliary Cancer

Study Overview

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

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.

Try a new drug association on this advanced cancer

Pancreatic Neoplasms
Biliary Tract Neoplasms

DRUG: Docetaxel
DRUG: Gemcitabine

RIO PANCREAS

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2005-12-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-06-29
First Submitted that Met QC Criteria 2005-12-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-06-30
First Posted (ESTIMATED) 2005-12-23	Results First Posted N/A	Last Verified 2011-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: unique Taxotère - Gemzar	DRUG: Docetaxel Docetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines DRUG: Gemcitabine Gemcitabine 1200 mg/m2 à J1 et J15 toutes les 4 semaines

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: unique

Taxotère - Gemzar

DRUG: Docetaxel

Docetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines

DRUG: Gemcitabine

Gemcitabine 1200 mg/m2 à J1 et J15 toutes les 4 semaines

Primary Outcome Measures	Measure Description	Time Frame
Overall response rate

Secondary Outcome Measures	Measure Description	Time Frame
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Chauvenet Laure, MD, ARCAGY/ GINECO GROUP

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record