Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer

NCT00153907 | Completed Phase 1

• 1 other identifier: 01-217
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

Xeloda; Navelbine; capecitabine; metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

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

  2 years

Interventions

Navelbine DRUG

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 DRUG

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

Also known as: Xeloda

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vinorelbine; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Craig A. Bunnell, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: March 1, 2002
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

US (2)