Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00153907

Purpose

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	Intervention	Phase
Breast Cancer	Drug: Navelbine Drug: Capecitabine	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Study of Oral Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Vinorelbine Vinorelbine tartrate Capecitabine

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To define the maximally tolerated dose and evaluate the feasibility and toxicity of capecitabine and oral navelbine administered in combination. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment:	40
Study Start Date:	March 2002
Estimated Study Completion Date:	August 2008
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153907

Locations

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

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Massachusetts General Hospital

Investigators

Principal Investigator:

Craig A. Bunnell, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Craig A. Bunnell, MD )
Study ID Numbers:	01-217
Study First Received:	September 8, 2005
Last Updated:	December 22, 2007
ClinicalTrials.gov Identifier:	NCT00153907 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Xeloda
Navelbine
capecitabine
metastatic breast cancer

Study placed in the following topic categories:

Antimetabolites
Capecitabine
Vinorelbine
Skin Diseases

Breast Neoplasms
Antineoplastic Agents, Phytogenic
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Breast Neoplasms

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Vinorelbine
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on August 30, 2009