Cabazitaxel With or Without Carboplatin in Treating Patients With Previously Treated Metastatic Castration-Resistant Prostate Cancer
NCT01505868 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 170
Last updated 2021-07-30
Summary
This partially randomized phase I/II trial studies cabazitaxel with or without carboplatin in treating patients with previously treated prostate cancer that has spread to other areas of the body and does not respond to treatment with hormones. Drugs used in chemotherapy, such as cabazitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cabazitaxel alone or with carboplatin is more effective in treating prostate cancer.
Conditions
- Castration Levels of Testosterone
- Castration-Resistant Prostate Carcinoma
- Lymphadenopathy
- Metastatic Prostate Carcinoma
- Prostate Adenocarcinoma
- Prostate Carcinoma Metastatic in the Bone
- Prostate Small Cell Carcinoma
Interventions
- DRUG
-
Cabazitaxel
Given IV
- DRUG
-
Given IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Paul Corn · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-07-11
- Primary Completion
- 2019-12-09
- Completion
- 2019-12-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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