Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00488982 · ClinicalTrials.gov registry record · Phase 2
Intermittent Chemotherapy With or Without Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) for Metastatic Hormone Refractory Prostate Cancer (HRPC)
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
NCT00488982: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT00488982 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 125 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00488982, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
Study Summary
This is a two-arm, randomized Phase II study of intermittent chemotherapy with and without GM-CSF. All patients will receive six 21-day cycles of docetaxel 75 mg/m2 on Day 2 of each cycle and 5 mg prednisone twice a day on Days 1-21. Following six cycles of chemotherapy, eligible subjects will be randomized to no maintenance therapy or to maintenance GM-CSF therapy. The GM-CSF group dose schedule will be 250 mcg/m2 subcutaneous (SQ) daily Days 15-28 every 28 days. Patients in both groups will continue until disease progression at which time GM-CSF will be discontinued and chemotherapy will again be administered.
Primary Outcome
The Kaplan-Meier product limit method with 95% confidence intervals will be used to estimate the median time to disease progression during initial course of randomized treatment
Interventions
- DRUG Docetaxel
- DRUG Docetaxel and GM-CSF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2007-04 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
What the finished NCT00488982 record still lists
NCT00488982 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT00488982 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00488982 about?
NCT00488982 is a clinical study titled "Intermittent Chemotherapy With or Without Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) for Metastatic Hormone Refractory Prostate Cancer (HRPC)". This is a two-arm, randomized Phase II study of intermittent chemotherapy with and without GM-CSF. All patients will receive six 21-day cycles of docetaxel 75 mg/m2 on Day 2 of each cycle and 5 mg prednisone twice a day on Days 1-21. Following six cycles of chemotherapy, eligible subjects will be ra...
What is the current status of trial NCT00488982?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2007-04. Estimated completion is 2014-05.
What interventions are being tested in trial NCT00488982?
The interventions under investigation include: Docetaxel (DRUG), Docetaxel and GM-CSF (DRUG).
Who is sponsoring clinical trial NCT00488982?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00488982's enrollment target sits among peer trials
125 558th of 2000 higher than 1,437 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
- NCT02717039 · 125 participants
Pharmacogenomics of Heparin-Induced Thrombocytopenia
- NCT02763033 · 125 participants · Phase 2
Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patients
- NCT02793999 · 125 participants
Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
- NCT03003299 · 125 participants · NA
PARTNER 3 Trial - Aortic Valve-in-Valve
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia