Bevacizumab With or Without Cyclophosphamide and Methotrexate: A Pilot Study in Women With Operable Breast Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Harold J. Burstein, MD, PhD
Study ID
NCT00121134
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Group A: Once every 3 weeks for 12 months Group B: Once every 3 weeks for 12 months
  • Cyclophosphamide — DRUG
    Once a day for 6 months
  • Methotrexate — DRUG
    Twice daily for the first two days of every week for 6 months
  • Capecitabine — DRUG
    Capecitabine: 2000 mg/m2 a day, on Days 1-14 of a 21 day cycle, for at total of 6 cycles (18 weeks) Bevacizumab: 15 mg/kg IV day 1 every 3 weeks x 1 year (17 cycles)

Study Details

The purpose of this research study is to study the effects (good and bad) of bevacizumab alone, bevacizumab with low-dose continuous chemotherapy (called metronomic chemotherapy), or bevacizumab with capecitabine, on you and your cancer. The goals of the study will be to: * Examine the safety of these drugs * See how easy or difficult it is to be treated with them * Monitor for any signs of recurrent cancer * Look at blood markers that might indicate how the treatment is working

Key Dates

First listed
Jul 21, 2005
Start date
Jun 30, 2005
Status verified
Nov 2013
Primary completion
May 31, 2009
Completion
May 31, 2011

Study Design

Enrollment
164 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    Bevacizumab Alone
  • Experimental: Group B
    Bevacizumab with cyclophosphamide and methotrexate
  • Experimental: Group C
    capecitabine, 14 days on/7 days off scheduling, and bevacizumab
  • Experimental: Group D
    capecitabine 7 days on/7 days off scheduling, and bevacizumab

Primary Outcome Measure

The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts [ Time Frame: 1 year ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94122-
Indiana University Cancer CenterIndianapolisIndiana46202-
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
University of North CarolinaDurhamNorth Carolina27701-

Find similar trials in San Francisco, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of California, San Francisco· San Francisco, CAIndiana University Cancer Center· Indianapolis, INBeth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAUniversity of North Carolina· Durham, NC

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