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Sponsors and Collaborators: |
US Oncology Research Bristol-Myers Squibb Pfizer |
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Information provided by: | US Oncology Research |
ClinicalTrials.gov Identifier: | NCT00248287 |
The purpose of this study is to determine the objective response rates produced by irinotecan and carboplatin therapy with or without Erbitux in patients with Metastatic Breast Cancer.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer |
Drug: Erbitux Drug: Irinotecan Drug: Carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Phase II Study of Weekly Irinotecan/Carboplatin (ICb) With or Without Cetuximab (Erbitux) in Patients With Metastatic Breast Cancer |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Male and female patients will be eligible for inclusion in this study if they meet all of the following criteria:
NOTE: Ascites, pleural effusion, and bone metastases are not considered measurable.
NOTE: Previously irradiated lesions will not be evaluable; however, these patients will still be eligible. Patients must have at least 1 measurable lesion at baseline.
NOTE: Availability of samples should be confirmed prior to randomization (at latest, prior to first dose).
EXCLUSION CRITERIA:
NOTE: If patient was receiving prior weekly or daily chemotherapy, he/she may begin study therapy 2 weeks after stopping prior therapy provided all toxicities have resolved; peripheral neuropathy must be less than Grade I as per exclusion criterion #8 above.
Principal Investigator: | Joyce A. O'Shaughnessy, MD | US Oncology Research |
Study ID Numbers: | CA225200 |
Study First Received: | November 2, 2005 |
Last Updated: | December 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00248287 |
Health Authority: | United States: Institutional Review Board |
Skin Diseases Cetuximab Irinotecan |
Breast Neoplasms Carboplatin Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |