Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). 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
Primary Outcome
The RP2D is the dose at which there are no dose-limiting toxicities (defined as a ≥grade 3 hematological toxicity related to lenalidomide).
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 |
What the finished NCT00942578 record still lists
NCT00942578 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.
NCT00942578 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00942578's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03383575 · 63 participants · Phase 2
Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome
- NCT04870944 · 63 participants · Phase 1
CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma
- NCT05031897 · 63 participants · Phase 2
Two Step Haplo With Radiation Conditioning
- NCT05312671 · 63 participants · Phase 2
Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI