A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

A Pilot Study of Taxotere (Docetaxel) Combined With Xeloda (Capecitabine) in the Treatment of Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214864
• Other study ID #: CRN-003
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2005
• Last updated: February 13, 2012
• Start date: December 2002

Study information

• Verified date: February 2012
• Source: Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

Combination chemotherapy has advantages over monochemotherapy due to the higher response rates that can often be obtained; by using agents with non-overlapping toxicity profiles, these responses can be achieved with less toxicity than maximally tolerated doses of single agents. One significant advantage of capecitabine/weekly docetaxel combination chemotherapy is that both agents appear to have a toxicity profile appropriate for palliative therapy of advanced breast cancer. This trial will utilize the usual schedule of capecitabine used in the USA, which is two times per day oral dosing for 14 days but at a reduced dose in hopes of decreasing toxicities. Docetaxel will be given weekly at a dose of 35 mg/m2 X 2 with a one-week rest to coincide with the 14-day schedule of capecitabine.

The primary objective is to evaluate the overall response rate (complete and partial responses) according to the RECIST criteria of the combination of capecitabine and docetaxel with the selected schedule in patients with advanced and/or metastatic breast cancer. The secondary objectives are to evaluate tolerability, time to tumor progression, and time to treatment failure of the combination of capecitabine and docetaxel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients with brain metastasis, adequately treated and stable and not requiring continued steroid medication will be eligible if no progression for > 3 months.

• Patients who have received any anti-cancer investigational agent in the month prior to inclusion.

• 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.

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• docetaxel, capecitabine
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

Locations

Country	Name	City	State
United States	Cancer Research Network, Inc.	Plantation	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Cancer Research Network	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To find the lowest tolerable efficacious dose of the docetaxel/capecitabine combination		2 years	No