Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00277069|
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : January 7, 2010
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Carboplatin Device: Capecitabine Drug: Vinorelbine||Phase 1 Phase 2|
- Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.
- Determine a maximum tolerated dose of capecitabine in combination with vinorelbine and carboplatin for this patient population.
- Determine the time to relapse after the administration of this regimen.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||INST: Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer|
|Study Start Date :||May 2000|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||March 2006|
- Drug: Carboplatin
Carboplatin given at 300mg/m2 IV over 30 minutes day 1, q 21 days
- Device: Capecitabine
Capecitabine is administered at 1500mg/m2 PO qd in 2 divided doses day 1-14 q 21 daysOther Name: Xeloda
- Drug: Vinorelbine
Vinorelbine: 25mg/m2 IV over 10 minutes day 1, 8 q 21 daysOther Name: Navelbine
- Measurable disease: Bidimensionally measurable lesions with clearly defined margins by 1) palpation with both diameters greater than 1 cm, 2) CT, MRI with both diameters greater than the distance between cuts of the imaging study. [ Time Frame: disease progression or unacceptable toxicities ]
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): NCT00277069
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Ian Rabinowitz, MD||University of New Mexico|