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

Part of paid clinical trials in Burbank, California.

Sponsor
R-Pharm
Study ID
NCT00370552
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg — DRUG
    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.
  • Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg — DRUG
    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.
  • Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 31, 2006
Start date
Mar 31, 2007
Status verified
Feb 2016
Primary completion
Nov 30, 2009
Completion
Nov 30, 2009

Study Design

Enrollment
136 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg
  • Experimental: Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg
  • Active Comparator: Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg

Primary Outcome Measure

Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study [ Time Frame: Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression ]

Locations (6)

FacilityCityStateZIPSite coordinators
East Valley Hematology And Oncology Medical GroupBurbankCalifornia91505-
Wilshire Oncology Medical Group, Inc.La VerneCalifornia91750-
Ucsf-Comprehensive Cancer CenterSan FranciscoCalifornia94115-
University Of Iowa Hospitals And ClinicsIowa CityIowa52242-
Ellis Fischel Cancer CenterColumbiaMissouri65203-
Weill Medical College Of Cornell UniversityNew YorkNew York10021-

Find similar trials in Burbank, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
East Valley Hematology And Oncology Medical Group· Burbank, CAWilshire Oncology Medical Group, Inc.· La Verne, CAUcsf-Comprehensive Cancer Center· San Francisco, CAUniversity Of Iowa Hospitals And Clinics· Iowa City, IAEllis Fischel Cancer Center· Columbia, MOWeill Medical College Of Cornell University· New York, NY

Related Studies