Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Capecitabine; Vinblastine; Vinorelbine

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