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NCT00077311 · ClinicalTrials.gov registry record · Phase 2
Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT00077311: Completed Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT00077311 is a Phase 2 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 160 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00077311, a Phase 2 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and inner ear damage) caused by chemotherapy. PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Primary Outcome
Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity
Interventions
- DRUG cisplatin
- DRUG docetaxel
- BIOLOGICAL pegfilgrastim
- BIOLOGICAL darbepoetin alfa
- DRUG BNP7787
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2004-08 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
What the finished NCT00077311 record still lists
NCT00077311 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.
NCT00077311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00077311 about?
NCT00077311 is a clinical study titled "Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer". RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and inner ear damage) caused by ...
What is the current status of trial NCT00077311?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2004-08. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00077311?
The interventions under investigation include: cisplatin (DRUG), docetaxel (DRUG), pegfilgrastim (BIOLOGICAL), darbepoetin alfa (BIOLOGICAL), BNP7787 (DRUG).
Who is sponsoring clinical trial NCT00077311?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00077311's enrollment target sits among peer trials
160 422nd of 2000 higher than 1,559 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
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