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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

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Uterine

Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma

Unique Dataset IDnci-data-422ClinicalTrial.gov IDNCT01012297
DownloadableNo
SponsorNational Cancer Institute (NCI)Data ProviderNational Cancer InstituteTotal Study Enrolled Patients107RandomizationYesPubMed (PMID)25713428.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypePlacebo, DrugDataset TypeOther

Clinical Trial Title

Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma

Trial Summary and Conditions

This 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.

Data Summary

See Data Dictionary.

Study Objectives

Primary:To determine whether the addition of bevacizumab to fixed-dose rate gemcitabine-docetaxel reduces the progression-free survival (PFS) event rate when compared to gemcitabine-docetaxel plus placebo in patients with advanced or recurrent uterine leiomyosarcoma (LMS). Secondary: To determine the objective response rate, as measured by RECIST, of patients treated with fixed-dose rate gemcitabine-docetaxel with bevacizumab, compared with the objective response rate of patients treated with fixed-dose rate gemcitabine-docetaxel with placebo; To determine if the addition of bevacizumab to the combination of gemcitabine and docetaxel increases overall survival in patients with advanced or recurrent uterine LMS; To determine the toxicity profile of fixed-dose rate gemcitabine-docetaxel with and without bevacizumab in this patient population;To bank formalin-fixed and paraffin-embedded (FFPE) tumor tissue for research;

Outcome Measures

Primary:Progression-free Survival [Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months] Secondary:Overall Survival [Time Frame: Up to 5 years]; Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0 [Time Frame: Up to 5 years]; Objective Response Rate as Measured by RECIST 1.1 Criteria [Time Frame: Up to 5 years]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

This dataset will allow users to reproduce the treatment comparison between Gemcitabine Plus Docetaxel Plus Bevacizumab and Gemcitabine Plus Docetaxel Plus Placebo

Available Downloads: NCT01012297-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT01012297-D1-Data-Dictionary_3.pdf

DATA: NCT01012297-D1-Dataset_2.csv

OTHER: README.pdf