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

NCT00583622 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2013-05-21

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Bevacizumab

5 mg/kg by vein daily over 90 minutes for 2 Days

DRUG

Carboplatin

333 mg/m\^2 by vein over 2 hours for 3 Days

DRUG

Docetaxel

300 mg/m\^2 by vein over 2 hours for 1 Day

DRUG

Gemcitabine

1,800 mg/m2 by vein over 3 hours for 4 Days

DRUG

Melphalan

50 mg/m\^2 by vein over 15 minutes for 3 Days

PROCEDURE

Stem Cell Transplant

* 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

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Yago Nieto, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00583622 on ClinicalTrials.gov