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NCT01012297 · ClinicalTrials.gov registry record · Phase 3
Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 3
- Development phase
- 107
- Enrollment target
NCT01012297: Clinical Trial Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT01012297 is a Phase 3 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 107 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01012297, a Phase 3 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 107 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan. Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the
Interventions
- DRUG Docetaxel
- BIOLOGICAL Filgrastim
- BIOLOGICAL Pegfilgrastim
- BIOLOGICAL Bevacizumab
- DRUG Gemcitabine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2009-11 |
| Est. Completion | 2015-09 |
| Phase | Phase 3 |
Why NCT01012297 stopped before completion
NCT01012297 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.
NCT01012297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01012297 about?
NCT01012297 is a clinical study titled "Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma". 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 ge...
What is the current status of trial NCT01012297?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2009-11. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01012297?
The interventions under investigation include: Docetaxel (DRUG), Filgrastim (BIOLOGICAL), Pegfilgrastim (BIOLOGICAL), Bevacizumab (BIOLOGICAL), Gemcitabine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01012297?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01012297's enrollment target sits among peer trials
107 1666th of 2000 higher than 335 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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