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

Pancreatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268840
• Other study ID #: RIO PANCREAS
• Status: Completed
• Phase: Phase 2
• First received: December 22, 2005
• Last updated: June 29, 2011
• Start date: August 2001
• Est. completion date: February 2006

Study information

• Verified date: June 2011
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

Try a new drug association on this advanced cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Neoplasms
• Pancreatic Neoplasms

Intervention

Drug:
• Docetaxel
Docetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines
• Gemcitabine
Gemcitabine 1200 mg/m2 à J1 et J15 toutes les 4 semaines

Locations

Country	Name	City	State
France	Hôpital Hôtel Dieu	Paris

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate
Secondary	Clinical benefit
Secondary	Progression-free survival
Secondary	Overall survival
Secondary	To evaluate the frequency and severity of the adverse events related to the combination of gemcitabine and docetaxel