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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 is a Phase 3 study that was terminated before completion, run by University of Kentucky. The registered enrollment target is 100 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00237575
The ClinicalTrials.gov registry entry for NCT00237575 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kentucky, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which cisplatin is the first listed.
NCT00237575 reports 0 study locations.
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.
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