Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00193102
• Other study ID #: SCRI BRE 60
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: May 2, 2011
• Start date: April 2001
• Est. completion date: June 2010

Study information

• Verified date: May 2011
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The lack of non-overlapping toxicities between the two drugs, the ease of all oral drug administration, and the possibility for antitumor synergy make exploration of this combination regimen attractive in women with previously treated metastatic breast cancer. This phase II trial will be performed in collaboration with the Minnie Pearl Cancer Research Network, a multicenter, community-based clinical trials group.

Description:

Upon determination of eligibility, patients will be receive:

Thalidomide + Capecitebine

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

• Metastatic breast cancer confirmed by biopsy

• Measurable or evaluable disease

• Females > 18 years

• Able to perform activities of daily living with minimal assistance

• Life expectancy > 3 months

• Adequate bone marrow, liver and kidney function

• All patients must give written informed consent in order to participate.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

• Women who are pregnant or lactating.

• Received more than 3 prior chemotherapy regimens in the metastatic setting.

• Received continuous infusion 5-fluorouracil lasting > 120 hours.

• Received thalidomide or capecitabine as their last prior regimen.

• Preexisting moderate to severe neuropathy

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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 Cancer
• Breast Neoplasms

Intervention

Drug:
• Thalidomide
Thalidomide
• Capecitabine
Capecitabine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Celgene Corporation

References & Publications (1)

Burris HA 3rd, Jones SF, Shipley D, Meluch AA, Greco FA, Barton JH, Yardley DA, Hainsworth JD. Phase II study of capecitabine in combination with thalidomide in patients with metastatic breast cancer. Cancer Invest. 2010 May;28(4):408-12. doi: 10.3109/073 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		18 Months	No

External Links

•   Published article in Cancer Investigation