Bevacizumab Plus Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Ovarian Cancer Patients

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00583622
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    5 mg/kg by vein daily over 90 minutes for 2 Days
  • Carboplatin — DRUG
    333 mg/m\^2 by vein over 2 hours for 3 Days
  • Docetaxel — DRUG
    300 mg/m\^2 by vein over 2 hours for 1 Day
  • Gemcitabine — DRUG
    1,800 mg/m2 by vein over 3 hours for 4 Days
  • Melphalan — DRUG
    50 mg/m\^2 by vein over 15 minutes for 3 Days
  • Stem Cell Transplant — PROCEDURE
    * Stem Cell Removal via apheresis through a central venous catheter (CVC), usually in chest * Stem Cell Replacement through CVC over about 30-60 minutes, Day 7 of treatment, following study drug regimen

Study Details

The goal of this clinical research study is to learn if bevacizumab, when given in combination with gemcitabine, docetaxel, melphalan and carboplatin, or with topotecan, cyclophosphamide and melphalan (if you are older than 60 or have an allergy to carboplatin), can help to control ovarian cancer during a stem cell transplant. The safety of this drug combination will also be studied.

Key Dates

First listed
Dec 31, 2007
Start date
Dec 31, 2007
Status verified
Apr 2013
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab + High-Dose Chemotherapy
    Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m\^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m\^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m\^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant

Primary Outcome Measure

Event-Free (EF) Rate [ Time Frame: Up to 6 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
U.T.M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
U.T.M.D. Anderson Cancer Center· Houston, TX

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