drugset / Trial / NCT01873326
Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors
Phase 2
Active not recruiting
92 enrolled
Memorial Sloan Kettering Cancer Center
Mayo Clinic · collabStanford University · collabUniversity of Chicago · collabUniversity of North Carolina · collabUniversity of Pittsburgh · collabUniversity of Southern California · collabUniversity of Texas Southwestern Medical Center · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to learn about the safety and effectiveness of two different drug combinations in patients who have intermediate- and poor-risk germ cell tumors (GCT). One combination of drugs, paclitaxel, ifosfamide and cisplatin (TIP), is experimental. The other combination of drugs, bleomycin, etoposide and cisplatin (BEP), is the standard of care treatment for intermediate- and poor-risk germ cell tumors. However, BEP does not cure every patient and therefore newer treatments are needed.
Timeline
- Start
- 2013-06
- Primary completion
- 2027-06
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bleomycin | Unknown | 30 iu | Intravenous |
| Subject | Cisplatin | Other / unclassified | 20 mg/m2 | Intravenous |
| Comparator | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Ifosfamide | Small molecule | 1200 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 120 mg/m2 | Intravenous |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 120 mg/m2 | Intravenous |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 1200 mg/m2 | Intravenous |