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Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine LeiomyosarcomaUnique Dataset IDnci-data-422ClinicalTrial.gov IDNCT01012297
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.
See Data Dictionary.
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;
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]
Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):
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