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NCT00957905 · ClinicalTrials.gov registry record · Phase 2
Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT00957905: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00957905 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00957905, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This phase II trial is studying alvocidib and oxaliplatin to see how well they work when given with or without fluorouracil and leucovorin calcium in treating patients with relapsed or refractory germ cell tumors. Drugs used in chemotherapy, such as alvocidib, oxaliplatin, fluorouracil, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving alvocidib together with oxaliplatin with or without fluorouracil and leucovorin calcium may kill more tumor cells.
Primary Outcome
Number of Participants with Partial Response (PR), Stable Disease (SD), Progression of Disease (POD) Per Response Evaluation Criteria In Solid Tumors Criteria" (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum o
Interventions
- DRUG Fluorouracil
- DRUG Oxaliplatin
- DRUG Leucovorin Calcium
- DRUG Alvocidib Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2009-06 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
What the finished NCT00957905 record still lists
NCT00957905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 4 interventions - of which Fluorouracil is the first listed.
NCT00957905 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00957905 about?
NCT00957905 is a clinical study titled "Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors". This phase II trial is studying alvocidib and oxaliplatin to see how well they work when given with or without fluorouracil and leucovorin calcium in treating patients with relapsed or refractory germ cell tumors. Drugs used in chemotherapy, such as alvocidib, oxaliplatin, fluorouracil, and leucovor...
What is the current status of trial NCT00957905?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2009-06. Estimated completion is 2014-08.
What interventions are being tested in trial NCT00957905?
The interventions under investigation include: Fluorouracil (DRUG), Oxaliplatin (DRUG), Leucovorin Calcium (DRUG), Alvocidib Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00957905?
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 NCT00957905's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 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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