Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00194727|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm||Drug: Vinorelbine Drug: Capecitabine||Phase 2|
Single-agent chemotherapy is rarely curative in advanced breast cancer. Combination regimens are the next logical step in the attempt to improve tumor response rates and prolong survival. Oral capecitabine is a convenient way to deliver drug a 5-fluorouracil analogue. In addition, vinorelbine is a newer vinca alkaloid chemotherapeutic agent with improved efficacy and probably improved toxicity over its predecessors in the treatment of breast cancer. We propose combining these two agents. As these two drugs have non-overlapping toxicities and differing mechanisms of action, we anticipate being able to deliver both drugs in near full dose.
Secondary purposes include assessing whether there is a correlation between intra-tumoral enzyme levels and prognosis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer: A Phase II Trial With Molecular Correlates|
|Study Start Date :||May 2002|
|Primary Completion Date :||March 2011|
|Study Completion Date :||March 2011|
Vinorelbine (20 mg/m2 IV weeks 1, 2 and 3 of each 3 week cycle) and capecitabine (825 mg/m2 twice a day; days 1 - 14 of each 3 week cycle). Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.
20 mg/m2 IV weeks 1, 2 and 3 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.Drug: Capecitabine
825 mg/m2 twice a day; days 1 - 14 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.
- Best response as determined at the time that the subject completes protocol treatment [ Time Frame: <= 4 years ]
- Time to progression as determined at the time that each subject's disease worsens following treatment [ Time Frame: <= 4 years ]
- Median survival at two and three years following the start of protocol treatment. [ Time Frame: <= 3 years ]
- Correlation between intra-tumoral enzyme levels and prognosis [ Time Frame: <= 4 years ]
- Measure the toxicity of the regimen [ Time Frame: During study treatment ]
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): NCT00194727
|United States, Washington|
|University of Washington; Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109-1023|
|Principal Investigator:||Georgiana K. Ellis, M.D.||University of Washington|