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Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00153907
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 7, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Navelbine Drug: Capecitabine Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Oral Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer
Study Start Date : March 2002
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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.
    Drug: Capecitabine
    Taken twice a day on days 1-14 until disease progression or unacceptable side effects occur.
    Other Name: Xeloda

Outcome Measures

Primary Outcome Measures :
  1. To define the maximally tolerated dose and evaluate the feasibility and toxicity of capecitabine and oral navelbine administered in combination. [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00153907

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Principal Investigator: Craig A. Bunnell, MD Dana-Farber Cancer Institute
More Information

Responsible Party: Craig A. Bunnell, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00153907     History of Changes
Other Study ID Numbers: 01-217
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

Keywords provided by Craig A. Bunnell, MD, MPH, Dana-Farber Cancer Institute:
metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators