Clinical trial NCT00153907: Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer
Official title: A Phase I Study of Oral Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Xeloda
Navelbine
capecitabine
metastatic breast cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts General Hospital
First posted: 2005-09-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: * 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.

Eligibility criteria: 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

Primary outcomes:
measure: To define the maximally tolerated dose and evaluate the feasibility and toxicity of capecitabine and oral navelbine administered in combination.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Craig A. Bunnell, MD
role: PRINCIPAL_INVESTIGATOR
References: