Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer
|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|
|Primary Completion Date :||March 2005|
|Study Completion Date :||March 2006|
- 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 ]
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|