Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Interventions

  • DRUG Docetaxel
  • BIOLOGICAL Filgrastim
  • BIOLOGICAL Pegfilgrastim
  • BIOLOGICAL Bevacizumab
  • DRUG Gemcitabine Hydrochloride

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2009-11
Est. Completion 2015-09
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01012297

The ClinicalTrials.gov registry entry for NCT01012297 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.

NCT01012297 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.