NCT00006010

Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer

Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable or Metastatic Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus docetaxel in treating patients who have unresectable or metastatic liver cancer.

Detailed description

OBJECTIVES: * Assess the six-month overall survival of patients with unresectable or metastatic hepatocellular carcinoma treated with gemcitabine and docetaxel. * Determine tumor response and time to progression in this patient population treated with this regimen. * Determine the toxicity of this regimen in these patients. * Assess the pharmacokinetics of docetaxel in patients treated with this regimen. OUTLINE: Patients receive docetaxel IV over 15-60 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks. Patients achieving complete response after 2 courses of therapy receive 2 additional courses of therapy. Patients with stable disease or partial response continue therapy until disease progression. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	docetaxel
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 2001-09-01
• Primary completion: 2004-05-01
• Completion: 2008-04-01
• First posted: 2003-01-27
• Last updated: 2016-12-07

Locations

17 sites across 2 countries: United States, Canada