Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153907
• Other study ID #: 01-217
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2005
• Last updated: February 5, 2013
• Start date: March 2002
• Est. completion date: September 2011

Study information

• Verified date: February 2013
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define the maximally tolerated dose and evaluate the feasibility and toxicity of capecitabine and oral navelbine administered in combination.		2 years	Yes