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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
2016-02
NCT00134056Uploaded 10-09-2021
Access via NCI by Request
PDS UID: nci-data-485
Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients With Advanced Hormone Refractory Prostate Cancer
Provider Information
Provider Data DescriptionThis dataset contains quality of life (QOL) data from trial NCT00134056 to reproduce the results reported in the Journal of Patient-Reported Outcomes (Unger et al, JPRO, 2018, PMID29951640).
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer. PURPOSE: This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy.
ConditionsMetastatic Cancer
Prostate Cancer
Intervention TypeDrug: atrasentan hydrochloride
Drug: docetaxel
Drug: prednisone
Other: placebo
Drug(s)Drug: docetaxel
Drug: prednisone
Drug: atrasentan hydrochloride
Total Enrolled1038
RandomizationRandomized
Blinding MethodTriple
Arms InterventionArm I: placebo - Active Comparator
Arm II: atrasentan hydrochloride - Experimental
Secondary IDS0421
PubMed (PMID)24616308
24565955
23871417
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00134056-D1
Data DictionaryNCT00134056-D1-Data-Dictionary_0.pdf
DATANCT00134056-D1-Dataset_0.csv
OTHERREADME.pdf
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