Carboplatin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Recruitment status was Recruiting
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.
Drug: gemcitabine hydrochloride
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Overall response rate (complete or partial response) [ Designated as safety issue: No ]
- Overall toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Estimated Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|Royal Bournemouth Hospital NHS Trust||Recruiting|
|Bournemouth, England, United Kingdom, BH7 7DW|
|Contact: Tamas Hickish, MD 44-1202-704-789 firstname.lastname@example.org|
|Portsmouth Oncology Centre at Saint Mary's Hospital||Recruiting|
|Portsmouth Hants, England, United Kingdom, PO3 6AD|
|Contact: Caroline Archer, MD 44-23-9228-6000 ext. 2363|
|Southampton General Hospital||Recruiting|
|Southampton, England, United Kingdom, SO16 6YD|
|Contact: Nicholas Murray, MD 44-238-079-5165|
|Study Chair:||Nicholas Murray, MD||University Hospital Southampton NHS Foundation Trust.|