Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00153907

Run by

Dana-Farber Cancer Institute

People needed

40

Starts

2002-03-01

Expected to finish

2011-09-01

Last updated by the study team

2013-02-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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