A Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab for Breast Cancer - Full Text View

Sponsored by:	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 subjects with MBC. The safety of this combination treatment will also be studied.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: Ixabepilone Drug: Bevacizumab Drug: Paclitaxel	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Bevacizumab Ixabepilone

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Response Rate [ Time Frame: 20 months after last patient first visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

duration of response [ Time Frame: 20 months after last patient first visit ] [ Designated as safety issue: No ]
time to response [ Time Frame: 20 months from last patient first visit ] [ Designated as safety issue: No ]
week 24 PFS (progression free survival) [ Time Frame: 20 months from last patient first visit ] [ Designated as safety issue: No ]
PFS and OS (overall survival) [ Time Frame: 20 months after last patient first visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	March 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Ixabepilone + Bevacizumab (Arm A): Experimental	Drug: Ixabepilone IV solution, Intravenous, 16 mg/m2, wkly x 3 q 4 wks, until PD or unacceptable toxicity Drug: Bevacizumab IV solution, IV, 10 mg/kg, q 2 wks, until PD or unacceptable toxicity
Ixabepilone + Bevacizumab (Arm B): Experimental	Drug: Ixabepilone IV solution, Intravenous, 40 mg/m2, every 3 wks, until PD or unacceptable toxicity Drug: Bevacizumab IV solution, IV, 15 mg/kg, every 3 wks until PD or unacceptable toxicity
Paclitaxel + Bevacizumab (Arm C): Active Comparator	Drug: Paclitaxel IV solution, Intravenous, 90 mg/m2, wkly x 3 every 4 wks, until PD or unacceptable toxicity Drug: Bevacizumab IV solution, IV, 10 mg/kg, q 2 wks, until PD or unacceptable toxicity

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men or women ages >=18 years
Histologic or cytologic confirmed diagnosis of invasive adenocarcinoma originating in the breast
At least one measurable lesion. Locally recurrent disease must be not be amenable to resection with curative intent
Subjects must not have received cytotoxic chemotherapy for locally recurrent/metastatic disease
Subjects who received prior adjuvant or neoadjuvant taxane therapy must have relapsed >=12 months after completing therapy
Subjects must not have breast cancer known to over express or amplify Her-2
Prior hormonal is allowed, but this must have been discontinued at least 2 weeks prior to randomization
Karnofsky performance status (PS) of 80-100 (or ECOG, PS of 0-1)
Adequate hematologic, hepatic and renal function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370552

Locations

United States, California
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
Tours Cedex, France, 37044
Local Institution
Saint Herblain, France, 44805
Local Institution
Marseille Cedex 9, France, 13273
Local Institution
Clermont-Ferrand, France, 63000
Local Institution
Paris Cedex 10, France, 75475
Local Institution
Besancon Cedex, France, 25030
Italy
Local Institution
Meldola Fc, Italy, 47014
Local Institution
Modena, Italy, 41100
Local Institution
Milano, Italy, 20132
Local Institution
Napoli, Italy, 80131
Local Institution
Cuneo, Italy, 12100
Local Institution
Roma, Italy, 00161
Spain
Local Institution
Hospitalet De Llobregat, Spain, 08907
Local Institution
Jaen, Spain, 23007
United Kingdom, Essex
Local Institution
Chelmsford, Essex, United Kingdom, CM1 7ET
United Kingdom, Greater Manchester
Local Institution
Manchester, Greater Manchester, United Kingdom, M20 4BX
United Kingdom, Nottinghamshire
Local Institution
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA163-115
Study First Received:	August 30, 2006
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00370552 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Epothilones
Tubulin Modulators
Breast Neoplasms
Antimitotic Agents

Bevacizumab
Angiogenesis Inhibitors
Antineoplastic Agents, Phytogenic
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Epothilones
Physiological Effects of Drugs
Mitosis Modulators
Breast Neoplasms
Bevacizumab
Antimitotic Agents
Angiogenesis Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on September 09, 2009