Carboplatin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00470249|
Recruitment Status : Terminated (Due to difficulty in recruitment)
First Posted : May 7, 2007
Last Update Posted : February 1, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Carboplatin Drug: Gemcitabine Hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||In this non-randomized prospective trial, patients with human epidermal growth factor 2 (HER-2)-negative locally advanced or metastatic breast cancer that was anthracycline- and taxane-resistant were treated with carboplatin at a dose equivalent to an area under the concentration-time curve of 4.5 mg/ml.min on day 1 and gemcitabine 1500 mg/m2 on day 2 of every 2-week cycle. The primary end point was overall response rate.|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 15, 2006|
|Actual Primary Completion Date :||November 3, 2008|
|Actual Study Completion Date :||November 3, 2008|
Experimental: 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
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
- Overall response rate (complete or partial response) [ Time Frame: 8 months ]Assess the Overall response rate (complete or partial response)
- Overall toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: 8 months ]Summary Overall toxicity as assessed by NCI CTCAE v3.0
- Overall survival [ Time Frame: 8 months ]Assess Overall survival
- Time to disease progression [ Time Frame: 8 months ]Assess Time to disease progression
- Duration of response [ Time Frame: 8 months ]Assess Duration of response
- Time to treatment failure [ Time Frame: 8 months ]Assess Time to treatment failure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470249
|Royal Bournemouth Hospital|
|Bournemouth, England, United Kingdom, BH7 7DW|
|Portsmouth Oncology Centre at Saint Mary's Hospital|
|Portsmouth, England, United Kingdom, PO3 6AD|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Study Chair:||Nicholas Murray, MD||University Hospital Southampton NHS Foundation Trust|