A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer

NCT00214864 | Completed Phase 2 DMC

• 1 other identifier: CRN-003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to attempt to find better tolerated doses and schedules of this highly effective combination chemotherapy regimen.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer; Taxotere (docetaxel); Xeloda (capecitabine)

Outcome Measures

Primary Outcomes (1)

• To find the lowest tolerable efficacious dose of the docetaxel/capecitabine combination

  2 years

Interventions

docetaxel, capecitabine DRUG

cohort 1 = capecitabine 900mg/m2 BID POx14 days and docetaxel 36mg/m2 day1\&8 cohort 2 = capecitabine 650mg/m2 BID POx14 days and docetaxel 30mg/m2 day1\&8 cohort 3 = capecitabine 850mg/m2 BID POx14 days and docetaxel 30mg/m2 day1\&8

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with histopathologically proven metastatic breast cancer.
• Patients 18-75 years old
• Performance status: Karnofsky \> 70%
• Patients must have measurable disease. Patients with only blastic bone lesions are ineligible.
• Adequate bone marrow, liver, renal and cardiac functions defined as:
• Ability to understand the study and give informed consent.
• Patients may not have received more than one prior chemotherapy for metastatic breast cancer. 5-FU or Taxol given as part of an adjuvant regimen will not render the patient ineligible.

You may not qualify if:

• Patients with brain metastasis, adequately treated and stable and not requiring continued steroid medication will be eligible if no progression for \> 3 months.
• Patients previously treated with docetaxel(Taxotere)or capecitabine (Xeloda).
• Patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome.
• Patients with renal impairment (creatinine clearance below 30 ml/min calculated according to Cockcroft and Gault, see Appendix D), since capecitabine is contraindicated in patients with severe renal impairment.

Sponsors & Collaborators

• Cancer Research Network: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Cancer Research Network, Inc.

Plantation, Florida, 33324, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Charles L Vogel, MD

  Cancer Research Network, Inc

  PRINCIPAL INVESTIGATOR

• Elizabeth Tan-Chiu, MD

  Cancer Research Network, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: December 1, 2002
• Primary Completion: January 1, 2006
• Last Updated: February 14, 2012

Record last verified: 2012-02

Locations

US (1)