A Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab for Breast Cancer

Phase 2

Completed

Conditions: Metastatic Breast Cancer

Interventions: 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

Registration Number: NCT00370552

Lead Sponsor: R-Pharm

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 136

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg	Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg	-
Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg	Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg	-
Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg	Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study	Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression	CR=Disappearance of all clinical and radiologic evidence of target lesions; PR=At least 30% reduction in the sum of the longest diameter of all target lesions.
Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)	Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression	Best tumor response was assessed with RECIST. Complete response (CR)=Disappearance of all evidence of target lesions; Partial response (PR)=At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions; Progressive disease (PD)=At least a 20% increase from baseline in the sum of LD of target lesions or the appearance of 1 or more new lesions; Stable disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. A response was confirmed if noted on 2 examinations at least 4 weeks apart.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Progression-free Survival at Week 24	Date of randomization to Week 24	Week 24 Progression-free Survival was defined as the number of participants who neither progressed nor died before Week 24. Computed using Kaplan-Meier estimates, only at the time of Interim Analysis, when all participants had been followed for 6 months.
Median Progression-free Survival (PFS)	Date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 29 months)	PFS was defined as the time from randomization to progression or to death from any cause without prior documentation of progression. Participants who did not progress or die were to be censored on the date of their last tumor assessment.
Median Time to Response	Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant time to response of 67 weeks)	Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for a PR or CR, whichever was recorded first. Time to response was computed only for participants whose best response was PR or CR.
Median Duration of Response	Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 25 weeks)	Duration of response was computed for participants whose best response was either PR or CR. Duration of overall response was defined as the period from the time that measurement criteria were first met for PR or CR, whichever was recorded first, until the first date of documented PD or death. Participants who neither relapsed nor died were to be censored on the date of their last tumor assessment.
Percentage of Participants Surviving at 1 Year	Date first participant enrolled to 1 year	One year survival rates were computed using Kaplan-Meier estimates.
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) Treatment-related SAEs, Treatment-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, Treatment-related AEs	At initiation of treatment throughout study, to a minimum of 30 days after last dose of study drug	An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade	At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle	CTC, Version 3 used to assess parameters. CTC Gr=Grade; WBC=white blood cells; ANC=absolute neutrophil count. LLN=lower level of normal. WBC Gr 1:\<LLN to 3.0\10\^9/L, Gr 2:\<3.0 to 2.0\10\^9/L, Gr 3:\<2.0 to 1.0\10\^9/L, Gr 4:\<1.0\10\^9/L; ANC Gr 1:\<LLN to 1.5\10\^9/L, Gr 2:\<1.5 to 1.0\10\^9/L, Gr 3:\<1.0 to 0.5\10\^9/L, Gr 4:\<0.5\10\^9/L; Platelet count Gr 1:LLN to 75.0\10\^9/L, Gr 2:\<75.0 to 50.0\10\^9/L, Gr 3:\<50.0 to 25.0\*10\^9/L, Gr 4:\<25.0 to 10\^9/L; Hemoglobin Gr 1:\<LLN to 10.0 g/dL, Gr 2:\<10.0 to 8.0 g/dL, Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL.
Number of Participants With Abnormalities in Liver Function by Worst CTC Grade	At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle	ULN=Upper limit of normal.ALT Gr 1:\>ULN to 2.5\ULN, Gr 2: \>2.5 to 5.0\ULN, Gr 3: \>5.0 to 20.0\ULN, Gr 4: \>20.0\ULN; AST Gr 1: \>ULN to 2.5\ULN, Gr 2: \>2.5 to 5.0\ULN, Gr 3: \>5.0 to 20.0\ULN, Gr 4: \>20.0\ULN; ALP Gr 1:\>ULN to 2.5\ULN, Gr 2: \>2.5 to 5.0\ULN, Gr 3: \>5.0 to 20.0\ULN, Gr 4: \>20.0\ULN; Total bilirubin Gr 1: \>ULN to 1.5\ULN, Gr 2: \>1.5 to 3.0\ULN, Gr 3: \>3.0 to 10.0\ULN, Gr 4: \>10.0\ULN.
Number of Participants With Abnormalities in Renal Function by Worst CTC Grade	At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle	Creatine Gr 1: \>ULN to 1.5\ULN, Gr 2: 1.5 to 3.0\ULN, Gr 3: \>3.0 to 6.0\ULN, Gr 4: \>6.0\ULN.

Trial Locations

Locations (7): East Valley Hematology And Oncology Medical Group
🇺🇸
Burbank, California, United States
Ellis Fischel Cancer Center
🇺🇸
Columbia, Missouri, United States
Ucsf-Comprehensive Cancer Center
🇺🇸
San Francisco, California, United States
Local Institution
🇬🇧
Merseyside, United Kingdom
Weill Medical College Of Cornell University
🇺🇸
New York, New York, United States
Wilshire Oncology Medical Group, Inc.
🇺🇸
La Verne, California, United States
University Of Iowa Hospitals And Clinics
🇺🇸
Iowa City, Iowa, United States