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
Overview
- Phase
- Phase 2
- Intervention
- Carboplatin
- Conditions
- Breast Cancer
- Sponsor
- University of Southampton
- Enrollment
- 5
- Locations
- 3
- Primary Endpoint
- Overall response rate (complete or partial response)
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Patients with (HER-2)-negative and anthracycline- and taxane-resistant
Patients with human epidermal growth factor 2 (HER-2)-negative locally advanced or metastatic breast cancer that was anthracycline- and taxane-resistant
Intervention: Carboplatin
Patients with (HER-2)-negative and anthracycline- and taxane-resistant
Patients with human epidermal growth factor 2 (HER-2)-negative locally advanced or metastatic breast cancer that was anthracycline- and taxane-resistant
Intervention: Gemcitabine Hydrochloride
Outcomes
Primary Outcomes
Overall response rate (complete or partial response)
Time Frame: 8 months
Assess the Overall response rate (complete or partial response)
Secondary Outcomes
- Overall toxicity as assessed by NCI CTCAE v3.0(8 months)
- Overall survival(8 months)
- Time to disease progression(8 months)
- Time to treatment failure(8 months)
- Duration of response(8 months)