NCT00470249

Carboplatin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Breast Cancer

A Phase II Study of Carboplatin in Combination With Gemcitabine as a Dose Dense Schedule in Patients With Locally Advanced or Metastatic Breast Cancer That Are Resistant to Anthracyclines & Taxanes

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Southampton · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin together with gemcitabine works in treating patients with locally advanced or metastatic breast cancer.

Detailed description

OBJECTIVES: Primary * Determine the overall response rate in patients with anthracycline- and taxane-resistant locally advanced or metastatic breast cancer treated with dose-dense carboplatin and gemcitabine hydrochloride. Secondary * Determine the overall toxicity of this regimen in these patients. * Determine the overall survival of patients treated with this regimen. * Determine the time to disease progression in patients treated with this regimen. * Determine the duration of response in patients treated with this regimen. * Determine the time to treatment failure in patients treated with this regimen. OUTLINE: This is a nonrandomized, open-label study. Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 150 minutes on day 2. Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically for 2 years. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	At a dose equivalent to an area under the concentration-time curve of 4.5 mg/ml.min on day 1 of every 2-week cycle
DRUG	Gemcitabine Hydrochloride	1500 mg/m2 on day 2 of every 2-week cycle

Timeline

• Start date: 2006-07-15
• Primary completion: 2008-11-03
• Completion: 2008-11-03
• First posted: 2007-05-07
• Last updated: 2021-02-01

Locations

3 sites across 1 country: United Kingdom