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NCT00237575 · ClinicalTrials.gov registry record · Phase 3
Randomized Phase III Trial of Leukine® vs Neupogen® in Patients Receiving Cisplatin & Gemcitabine for Urothelial Cancer
A Phase 3 study, sponsored by University of Kentucky.
- Terminated
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
NCT00237575: Clinical Trial Phase 3 study, sponsored by University of Kentucky.
NCT00237575 is a Phase 3 study that was terminated before completion, run by University of Kentucky. The registered enrollment target is 100 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00237575, a Phase 3 study, was terminated before completion, sponsored by University of Kentucky.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
Study Summary
The main objective of this study is to compare the effectiveness of Leukine \& Neupogen to decrease the incidence of grade 3 \& 4 neutropenia in the treatment of patients receiving cisplatin \& gemcitabine for urothelial (bladder) cancer. All patients will receive chemotherapy with cisplatin plus gemcitabine in six 21-day cycles. Patients will also receive either Leukine (Arm A) or Neupogen (Arm B). Patient Population: 100 patients will be enrolled (n=100) in this study. Patients cannot have undergone previous chemotherapy. Approximately 50 patients will be enrolled into each treatment arm. Test Product, Dose, Mode of Administration: All patients will receive chemotherapy treatment with cisplatin (70 mg/kg) on Day 1 and gemcitabine (1000 mg/m2) on Days 1, 8, \& 15 of each 21-day cycle. Patients will be randomized to receive either Leukine (250 µg/m2) or Neupogen (5 µg/kg) injected under the skin on Days 2-6, 9-13, \& 16-20 of each cycle. Duration of Treatment: Patients will receive a maximum of six 21-day cycles of treatment. The overall trial, including follow-up, is expected to be 3 years in duration.
Interventions
- DRUG cisplatin
- DRUG gemcitabine
- DRUG filgrastim
- DRUG sargramostim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2005-11 |
| Est. Completion | 2006-03 |
| Phase | Phase 3 |
Why NCT00237575 stopped before completion
NCT00237575 is an interventional study that assigns participants to a tested intervention. The registered 100 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 (87% lower).
The record links to 0 conditions, and to 4 interventions - of which cisplatin is the first listed.
NCT00237575 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00237575 about?
NCT00237575 is a clinical study titled "Randomized Phase III Trial of Leukine® vs Neupogen® in Patients Receiving Cisplatin & Gemcitabine for Urothelial Cancer". The main objective of this study is to compare the effectiveness of Leukine \& Neupogen to decrease the incidence of grade 3 \& 4 neutropenia in the treatment of patients receiving cisplatin \& gemcitabine for urothelial (bladder) cancer. All patients will receive chemotherapy with cisplatin plus g...
What is the current status of trial NCT00237575?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2005-11. Estimated completion is 2006-03.
What interventions are being tested in trial NCT00237575?
The interventions under investigation include: cisplatin (DRUG), gemcitabine (DRUG), filgrastim (DRUG), sargramostim (DRUG).
Who is sponsoring clinical trial NCT00237575?
This trial is sponsored by University of Kentucky, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00237575's enrollment target sits among peer trials
100 1681st of 2000 higher than 288 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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