Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00153907|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Navelbine Drug: Capecitabine||Phase 1|
- Not every patient will be receiving the same dose of capecitabine and navelbine. A small group will be enrolled onto the study and given certain doses of each drug. If they tolerate them well (have few or easily manageable side effects), the next small group of people enrolled will receive a higher dose of one of the drugs. This will continue until we find the highest doses of the drugs that can be given without causing serious or unmanageable side effects.
- Patients will be given oral navelbine on days 1 and 8 of each cycle, unless they are at the highest dose. In which case, they will be given navelbine on days 1, 8 and 15. Capecitabine will be given on days 1-14 of each cycle in two divided doses approximately 12 hours apart.
- While patients are on the study they will have the following tests and procedures performed: physical examination every 3 weeks; routine blood work every week; extensive laboratory tests every 3 weeks; disease status will be checked every 6 weeks (2 cycles) unless there are symptoms of disease progression.
- The weekly treatment will continue unless there is disease progression or unacceptable side effects.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Oral Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer|
|Study Start Date :||March 2002|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
- Drug: Navelbine
Given orally on day 1 and 8 of each cycle, dose will vary. If participant is at highest dose they will take navelbine on day 1, 8 and 15 until disease progression or unacceptable side effects occur.
- Drug: Capecitabine
Taken twice a day on days 1-14 until disease progression or unacceptable side effects occur.Other Name: Xeloda
- To define the maximally tolerated dose and evaluate the feasibility and toxicity of capecitabine and oral navelbine administered in combination. [ Time Frame: 2 years ]
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): NCT00153907
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Craig A. Bunnell, MD||Dana-Farber Cancer Institute|