Carboplatin and Paclitaxel With or Without Cediranib Maleate in Treating Patients With Metastatic or Recurrent Cervical Cancer That Cannot Be Removed by Surgery
NCT01229930 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2013-08-26
Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether carboplatin and paclitaxel are more effective when given with or without cediranib maleate in treating patients with cervical cancer that cannot be removed by surgery.
PURPOSE: This randomized phase II trial is studying giving carboplatin and paclitaxel together with cediranib maleate to see how well it works compared with giving carboplatin and paclitaxel together with a placebo in treating patients with metastatic or recurrent cervical cancer that cannot be removed by surgery.
Conditions
Interventions
- DRUG
- DRUG
-
cediranib maleate
- DRUG
- OTHER
-
laboratory biomarker analysis
- OTHER
-
pharmacological study
- PROCEDURE
-
quality-of-life assessment
Sponsors & Collaborators
-
University of Glasgow
lead OTHER
Principal Investigators
-
R. Paul Symonds, MD, FRCP, FRCR · University Hospitals, Leicester
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2012-12-31
- Completion
- 2012-12-31
Countries
- United Kingdom
Study Locations
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