NCT00611962

Phase II Study of Oxaliplatine-Paclitaxel in Patients With Metastatic Germ Cell Tumor Refractory to Cisplatin

Phase II Study of Combined Oxaliplatin and Paclitaxel for Metastatic Germ Cell Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of the oxaliplatin-paclitaxel combination i.e. evaluation of tumor response rate using World Health Organization/Union Internationale Contre le Cancer (WHO/UICC) and Indianapolis tumor marker (human chorionic gonadotropin \[hCG\], alpha fetoprotein \[AFP\]) criteria in metastatic germ cell cancer patients

Conditions

• Neoplasms, Germ Cell and Embryonal

Interventions

Type	Name	Description
DRUG	Oxaliplatin, Paclitaxel	Oxaliplatin was provided in clear glass vials sealed with a rubber stopper and an aluminum seal with a flip-off cover. Each vial contained 50 or 100 mg of active ingredient with 450 or 900 mg, respectively, of lactose monohydrate as excipient Paclitaxel was supplied as single dose vials of 30 mg/5 mL or 100 mg/17 mL.

Timeline

• Start date: 2000-12-01
• Completion: 2004-03-01
• First posted: 2008-02-11
• Last updated: 2008-02-11

Locations

1 site across 1 country: France