Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

NCT00193102 | Terminated Phase 2

• 1 other identifier: SCRI BRE 60
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  18 Months

Interventions

Thalidomide DRUG

Thalidomide

Capecitabine DRUG

Capecitabine

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Celgene Corporation: collaborator

Related 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: 10.3109/07357901003631049.

  PMID: 20210519 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Thalidomide; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Howard Burris, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: April 1, 2001
• Primary Completion: February 1, 2005
• Study Completion: June 1, 2010
• Last Updated: May 3, 2011

Record last verified: 2011-05