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| Sponsor: | US Oncology Research |
|---|---|
| Information provided by: | US Oncology Research |
| ClinicalTrials.gov Identifier: | NCT01075100 |
Purpose
Ixabepilone adds significantly to the antitumor effectiveness of capecitabine in both ER+ and triple negative breast cancer. Ixabepilone has substantial antitumor activity in taxane-refractory patients and novel combinations are needed in this poor prognosis population. Carboplatin in combination with gemcitabine or paclitaxel has activity in metastatic breast cancer (MBC); there is also demonstrated activity of the gemcitabine/carboplatin combination in the ER+ versus triple negative subsets. A Phase I study of ixabepilone plus carboplatin in solid tumor patients demonstrated the safety of this combination at the doses and schedule proposed for this Phase II trial (BMS data on file).
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: Ixabepilone Drug: Carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Ixabepilone Plus Carboplatin in Patients With Metastatic Breast Cancer: The ECLIPSE Study |
| Estimated Enrollment: | 103 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Weekly Ixabepilone +carboplatin for metastatic breast cancer
Subjects will receive ixabepilone and carboplatin on Days 1 and 8 of each 21-day cycle.
|
Drug: Ixabepilone
20 mg/m2 on Days 1 and 8
Drug: Carboplatin
carboplatin AUC=2.5 on Days 1 and 8
|
This is a Phase II, open label, nonrandomized, parallel, noncomparative, study of 2 groups (as stratified below). All patients will receive ixabepilone 20 mg/m2 on Days 1 and 8 and carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle. Patients will be stratified by either hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]- (n=50) or triples negative ER-/PR-/HER2- (n=53). If one group fulfills their accrual goal first, registration into that strata will be stopped and only patients meeting stratification requirements for the other group will be registered.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male or female patients will be eligible for inclusion in this study if they meet all of the following criteria:
Has received up to 2 (0 to 2) prior chemotherapy regimens for metastatic disease with the following conditions:
•Has had no prior treatment with ixabepilone or platinum agents
Has laboratory values of:
White blood cell (WBC) count ≥3000 x 106/L Absolute neutrophil count (ANC) ≥1500 x 106/L Hemoglobin ≥9 g/dL Total bilirubin ≤1x upper limit of normal (ULN) AST and ALT ≤2.5 x ULN Alkaline phosphatase ≤2.5 x ULN; up to 5xULN if elevation is due to bone disease Serum creatinine ≤1.5 mg/dL Calculated creatinine clearance >50 mL/min (based on Cockroft and Gault method [Appendix III]) Platelet count ≥100,000 x 106/L
Exclusion Criteria:
A patient will be excluded from this study if he or she meets any of the following criteria:
Contacts and Locations
Show 59 Study Locations| Principal Investigator: | Cynthia R Osborne, MD | US Oncology |
More Information
| Responsible Party: | US Oncology |
| ClinicalTrials.gov Identifier: | NCT01075100 History of Changes |
| Other Study ID Numbers: | 08007 |
| Study First Received: | January 14, 2010 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
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metastatic breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Carboplatin Epothilones |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |