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Type(s) of Cancer
Uterine
Study Phase
Phase 3
Study Completion Date
September 2015
NCT01012297Uploaded 08-21-2020
Access via NCI by Request
PDS UID: nci-data-422
A Randomized Phase III Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Bevacizumab (NSC #704865) Versus Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Placebo in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce the treatment comparison between Gemcitabine Plus Docetaxel Plus Bevacizumab and Gemcitabine Plus Docetaxel Plus Placebo
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial is studying gemcitabine hydrochloride, docetaxel, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, docetaxel, and a placebo in treating patients with advanced or recurrent uterine leiomyosarcoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether gemcitabine hydrochloride and docetaxel are more effective when given with or without bevacizumab in treating uterine leiomyosarcoma.
ConditionsRecurrent Uterine Corpus Sarcoma
Stage IIIA Uterine Sarcoma
Stage IIIB Uterine Sarcoma
Stage IIIC Uterine Sarcoma
Stage IVA Uterine Sarcoma
Stage IVB Uterine Sarcoma
Uterine Corpus Leiomyosarcoma
Intervention TypeBiological: Bevacizumab
Drug: Docetaxel
Biological: Filgrastim
Drug: Gemcitabine Hydrochloride
Biological: Pegfilgrastim
Other: Placebo
Drug(s)Drug: Docetaxel
Drug: Gemcitabine Hydrochloride
Total Enrolled107
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I Gem+Doce+Placebo - Experimental
Arm II Gem+Doce+Bev - Experimental
Secondary IDNCI-2010-01738
PubMed (PMID)34298376
25713428
Collaborator(s)NRG Oncology
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Files: NCT01012297-D1
Data DictionaryNCT01012297-D1-Data-Dictionary_3.pdf
DATANCT01012297-D1-Dataset_2.csv
OTHERREADME.pdf
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