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NCT00942578 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Trial of Bevacizumab, Lenalidomide, Docetaxel, and Prednisone (ART-P) for Treatment of Metastatic Castrate-Resistant Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT00942578: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00942578 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 63 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00942578, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
Background: * Prednisone and docetaxel have been used successfully in treating patients with prostate cancer, either when used alone or in combination with other agents. Researchers believe that these anticancer effects can be increased by giving them in this specific combination. * A previous study at the National Cancer Institute combined docetaxel and prednisone with bevacizumab and thalidomide. The results of this study were promising; however, most patients in the study required a dose reduction of thalidomide because of its side effects. * Lenalidomide, a drug similar to thalidomide, may have less severe side effects. Based on previous studies, lenalidomide is well tolerated in patients with solid tumors when used alone or in combination with docetaxel, and it may be a good substitute for thalidomide. Objectives: * To determine if lenalidomide is an appropriate and effective substitute for thalidomide in treating prostate cancer. * To evaluate the safety and effectiveness of bevacizumab, lenalidomide, docetaxel, and prednisone as a prostate cancer treatment, and to study any side effects. Eligibility: \- Men 18 years of age and older who have been diagnosed with metastatic prostate cancer that has not responded to standard treatment, including surgical removal of the testicles or treatment with androgen (sex-hormone) suppressing drugs. Design: * Participants will have a complete medical history and physical examination before beginning the study. * Patients will be treated with 21-day cycles with a combination of four drugs: * (1) Docetaxel, which will be given into a vein for 60 minutes on the first day of each 21-day cycle. Patients will take dexamethasone (a steroid agent) before and after taking docetaxel. * (2) Prednisone, which will be taken by mouth daily. * (3) Bevacizumab, which will be given through a vein over 30 to 90 minutes on the first day of each 21-day cycle following the infusion of docetaxel. * (4) Lenalidomide, which will be taken by
Interventions
- DRUG Bevacizumab
- DRUG Docetaxel
- DRUG Lenalidomide
- DRUG Prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2009-07-16 |
| Est. Completion | 2017-07-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00942578
The ClinicalTrials.gov registry entry for NCT00942578 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 63 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 4 interventions - of which Bevacizumab is the first listed.
NCT00942578 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00942578 about?
NCT00942578 is a clinical study titled "A Phase 2 Trial of Bevacizumab, Lenalidomide, Docetaxel, and Prednisone (ART-P) for Treatment of Metastatic Castrate-Resistant Prostate Cancer". Background: * Prednisone and docetaxel have been used successfully in treating patients with prostate cancer, either when used alone or in combination with other agents. Researchers believe that these anticancer effects can be increased by giving them in this specific combination. * A previous stud...
What is the current status of trial NCT00942578?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2009-07-16. Estimated completion is 2017-07-31.
What interventions are being tested in trial NCT00942578?
The interventions under investigation include: Bevacizumab (DRUG), Docetaxel (DRUG), Lenalidomide (DRUG), Prednisone (DRUG).
Who is sponsoring clinical trial NCT00942578?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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