Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Thalidomide Drug: Capecitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer |
- Overall response rate [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2001 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
-
Drug: Thalidomide
Upon determination of eligibility, patients will be receive:
Thalidomide + Capecitebine
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | SCRI Oncology Research Consortium, SCRI |
| ClinicalTrials.gov Identifier: | NCT00193102 History of Changes |
| Other Study ID Numbers: | SCRI BRE 60 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Thalidomide Fluorouracil Capecitabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013