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

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARCAGY/ GINECO GROUP
• Treatments: Docetaxel; Gemcitabine

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