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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00370552 |
Purpose
The purpose of this clinical research study is to learn if ixabepilone plus bevacizumab is effective in shrinking or stopping the growth of cancer when given as first-line chemotherapy in participants with metastatic breast cancer. The study will also assess the safety of this combination treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg Drug: Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg Drug: Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Open Label, Randomized, 3 Arm Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab as First Line Therapy for Locally Recurrent or Metastatic Breast Cancer |
| Enrollment: | 136 |
| Study Start Date: | March 2007 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg |
Drug: Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg
Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
Other Names:
|
| Experimental: Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg |
Drug: Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg
Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity (After Cycle 4, dose reduction to 32 mg/m^2 was to be implemented for all subsequent cycles.) Bevacizumab, 15 mg/kg, administered as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
Other Names:
|
| Active Comparator: Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg |
Drug: Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg
Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| United States, California | |
| East Valley Hematology And Oncology Medical Group | |
| Burbank, California, United States, 91505 | |
| Wilshire Oncology Medical Group, Inc. | |
| La Verne, California, United States, 91750 | |
| Ucsf-Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Iowa | |
| University Of Iowa Hospitals And Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center | |
| Columbia, Missouri, United States, 65203 | |
| United States, New York | |
| Weill Medical College Of Cornell University | |
| New York, New York, United States, 10021 | |
| France | |
| Local Institution | |
| Besancon Cedex, France, 25030 | |
| Local Institution | |
| Clermont-Ferrand, France, 63000 | |
| Local Institution | |
| Marseille Cedex 9, France, 13273 | |
| Local Institution | |
| Paris Cedex 10, France, 75475 | |
| Local Institution | |
| Saint Herblain, France, 44805 | |
| Local Institution | |
| Strasbourg Cedex, France, 67085 | |
| Local Institution | |
| Tours Cedex, France, 37044 | |
| Italy | |
| Local Institution | |
| Cuneo, Italy, 12100 | |
| Local Institution | |
| Meldola Fc, Italy, 47014 | |
| Local Institution | |
| Milano, Italy, 20132 | |
| Local Institution | |
| Modena, Italy, 41100 | |
| Local Institution | |
| Napoli, Italy, 80131 | |
| Local Institution | |
| Roma, Italy, 00161 | |
| Spain | |
| Local Institution | |
| Hospitalet De Llobregat, Spain, 08907 | |
| Local Institution | |
| Jaen, Spain, 23007 | |
| United Kingdom | |
| Local Institution | |
| Chelmsford, Essex, United Kingdom, CM1 7ET | |
| Local Institution | |
| Manchester, Greater Manchester, United Kingdom, M20 4BX | |
| Local Institution | |
| Nottingham, Nottinghamshire, United Kingdom, NG5 1PB | |
| Local Institution | |
| Merseyside, United Kingdom, CH63 4JY | |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00370552 History of Changes |
| Other Study ID Numbers: | CA163-115 |
| Study First Received: | August 30, 2006 |
| Results First Received: | March 24, 2011 |
| Last Updated: | May 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Epothilones Bevacizumab Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |