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

Phase 1
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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

- 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.

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

Type of Study:


Study Design:

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

Outcome Measure:

To define the maximally tolerated dose and evaluate the feasibility and toxicity of capecitabine and oral navelbine administered in combination.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Craig A. Bunnell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

March 2002

Completion Date:

September 2011

Related Keywords:

  • Breast Cancer
  • Xeloda
  • Navelbine
  • capecitabine
  • metastatic breast cancer
  • Breast Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617