NCT00002998

Gemcitabine and Cisplatin in Treating Patients With Metastatic Breast Cancer

Phase II Study of Gemcitabine (GEMZAR) and Cisplatin (CDDP) in Advanced Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (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 drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine and cisplatin in treating patients with metastatic breast cancer that has not responded to systemic therapy.

Detailed description

OBJECTIVES: I. Assess the response rate of gemcitabine and cisplatin in the treatment of metastatic breast cancer in patients who have failed one or two systemic regimens. II. Determine time to progression and survival in these patients. III. Define further the toxicity of this two-drug combination in these patients. OUTLINE: This is a nonrandomized study. Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, and 15 every 28 days. Patients with complete response may receive an additional 2 courses after attainment of complete response status. Treatment continues in the absence of disease progression or unacceptable toxicities for a maximum of 8 courses. Patients are followed every 3 months for 2 years and then at 3 years after treatment.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 1997-08-01
• Primary completion: 2005-04-01
• Completion: 2006-05-01
• First posted: 2004-07-19
• Last updated: 2016-07-13

Locations

20 sites across 2 countries: United States, Canada