Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to find the highest dose of capecitabine and oral navelbine that can be given without causing severe side effects, and to determine the safety, tolerability, and effects (good and bad) of capecitabine given with oral navelbine to patients with advanced breast cancer.

Detailed Description
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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.

Official Title
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A Phase I Study of Oral Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Navelbine
* Drug: Capecitabine


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the maximally tolerated dose and evaluate the feasibility and toxicity of capecitabine and oral navelbine administered in combination. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xeloda, Navelbine, capecitabine, metastatic breast cancer