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
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
-
5 mg/kg by vein daily over 90 minutes for 2 Days
- DRUG
-
333 mg/m\^2 by vein over 2 hours for 3 Days
- DRUG
-
300 mg/m\^2 by vein over 2 hours for 1 Day
- DRUG
-
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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