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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 February 2013 |
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Main ID: |
NCT00153907 |
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Date of registration:
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08/09/2005 |
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Primary sponsor: |
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Public title:
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Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer
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Scientific title:
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A Phase I Study of Oral Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer |
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Date of first enrolment:
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March 2002 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00153907 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Craig A. Bunnell, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dana-Farber Cancer Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically confirmed breast cancer with evidence of locally advanced or
metastatic disease
- Female patients age 18 or older
- No more than three prior chemotherapeutic regimens in the metastatic setting
- ANC > 1,500/mm3
- Platelet count > 100,000/mm3
- SGOT < 3 x ULN
- Bilirubin < 1.5 x ULN
- Performance status of 0 or 1
- At least 3 weeks since prior chemotherapy or 2 weeks since prior radiation, surgery
or any anticancer investigational agent
- Able to swallow and retain oral medications
- Measurable disease
Exclusion Criteria:
- Prior vinca alkaloids
- Active gastrointestinal disease or disorder
- Pregnant or lactating
- Serious co-morbid medical or psychological condition
- Prior bone marrow or stem cell transplant
- Prior documented severe sensitivity to 5-FU
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: Capecitabine
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Drug: Navelbine
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Primary Outcome(s)
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To define the maximally tolerated dose and evaluate the feasibility and toxicity of capecitabine and oral navelbine administered in combination.
[Time Frame: 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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