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

ARCAGY/ GINECO GROUP

Status and phase

Completed

Phase 2

Conditions

Biliary Tract Neoplasms

Pancreatic Neoplasms

Treatments

Drug: Gemcitabine

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00268840

RIO PANCREAS

Details and patient eligibility

About

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.

Full description

Try a new drug association on this advanced cancer

Enrollment

45 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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