Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer

NCT ID: NCT00153907

Last Updated: 2013-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2011-09-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Capecitabine

Taken twice a day on days 1-14 until disease progression or unacceptable side effects occur.

Intervention Type: DRUG

Other Intervention Names

Xeloda

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Craig A. Bunnell, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig A. Bunnell, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

01-217

Identifier Type: -

Identifier Source: org_study_id