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NCT00423852 · ClinicalTrials.gov registry record · Phase 1
Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00423852: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00423852 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00423852, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. An autologous peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed. PURPOSE: This phase I/II trial is studying the side effects and best dose of ifosfamide when given together with paclitaxel and carboplatin followed by an autologous stem cell transplant and to see how well they work in treating patients with germ cell tumors that did not respond to cisplatin.
Primary Outcome
Response assessed at the completion of therapy (after four to five cycles of chemotherapy and after surgery if necessary) Complete Response (CR): A complete response is defined as one of the following: * Complete disappearance of all clinical and radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy). * Complete disappearance of all biochemical evidence of disease with resection of residual radiographic masses that prove to be negati
Interventions
- DRUG carboplatin
- DRUG paclitaxel
- PROCEDURE autologous hematopoietic stem cell transplantation
- DRUG ifosfamide
- BIOLOGICAL filgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2006-08 |
| Est. Completion | 2013-02 |
| Phase | Phase 1 |
What the finished NCT00423852 record still lists
NCT00423852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 5 interventions - of which carboplatin is the first listed.
NCT00423852 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00423852 about?
NCT00423852 is a clinical study titled "Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin". RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. An autologo...
What is the current status of trial NCT00423852?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2006-08. Estimated completion is 2013-02.
What interventions are being tested in trial NCT00423852?
The interventions under investigation include: carboplatin (DRUG), paclitaxel (DRUG), autologous hematopoietic stem cell transplantation (PROCEDURE), ifosfamide (DRUG), filgrastim (BIOLOGICAL).
Who is sponsoring clinical trial NCT00423852?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00423852's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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