drugset / Trial / NCT00559429
Study of Docetaxel +153 Sm-EDTMP in Patients With Hormone-Refractory Prostate Cancer
Phase 1
Completed
13 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Cytogen Corporation · collabSanofi · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective of the study is to determine a recommended phase II dose (RP2D). The secondary objective of the study are: 1. To evaluate preliminary incidence and duration of clinical benefits as determined by improvements of pain, PSA decline and bone scan changes. 2. To evaluate the toxicity profile of the escalating doses of Docetaxel in combination with Samarium 153 in patients with advanced, hormone refractory prostate cancer metastatic to the bone.
Timeline
- Start
- 2004-12
- Primary completion
- 2008-10
- Completion
- 2008-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 153 Sm-EDTMP | Unknown | 1 unknown | Intravenous |
| Comparator | Docetaxel | Small molecule | 50 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |