drugset / Trial / NCT00551122
Gemcitabine, Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Progressive or Relapsed Metastatic Germ Cell Tumors
Phase 1/2
Unknown
23 enrolled
University of Southampton
University Hospital Southampton NHS Foundation Trust · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, ifosfamide, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with paclitaxel, ifosfamide, and cisplatin, and to see how well they work in treating patients with progressive or relapsed metastatic germ cell tumors.
Timeline
- Start
- 2006-11
- Primary completion
- 2013-04
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 1200 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 20 mg/m2 | Intravenous |
| Background | Ifosfamide | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Lenograstim | Protein / enzyme biologic | — | Subcutaneous |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | Subcutaneous |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |