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

Sponsored by:	ARCAGY/ GINECO GROUP
Information provided by:	ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:	NCT00268840

Purpose

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.

Condition	Intervention	Phase
Pancreatic Neoplasms Biliary Tract Neoplasms	Drug: Docetaxel Drug: Gemcitabine	Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Docetaxel Gemcitabine hydrochloride Gemcitabine Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by ARCAGY/ GINECO GROUP:

Primary Outcome Measures:

Overall response rate

Secondary Outcome Measures:

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

Enrollment:	45
Study Start Date:	August 2001
Estimated Study Completion Date:	December 2010

Arms	Assigned Interventions
unique: Experimental 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

Detailed Description:

Try a new drug association on this advanced cancer

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268840

Locations

France
Hôpital Hôtel Dieu
Paris, France, 75004

Sponsors and Collaborators

ARCAGY/ GINECO GROUP

Investigators

Study Chair:

Chauvenet Laure, MD

ARCAGY/ GINECO GROUP

More Information

Study ID Numbers:	RIO PANCREAS
Study First Received:	December 22, 2005
Last Updated:	September 4, 2007
ClinicalTrials.gov Identifier:	NCT00268840
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by ARCAGY/ GINECO GROUP:

Pancreas or biliary cancer

Study placed in the following topic categories:

Biliary Tract Neoplasms
Digestive System Neoplasms
Pancreatic Neoplasms
Biliary tract cancer
Endocrine System Diseases
Pancrelipase
Docetaxel
Digestive System Diseases

Biliary Tract Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009