NCT00531687

Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer

Phase II Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Study Objectives: Primary objective * The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP. Secondary Objectives * Overall survival * Progression free survival * Response rates (RECIST) * Duration of response * To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP

Detailed description

not relevant

Conditions

• Testicular Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	Paclitaxel 175 mg/m2 day 1 (3 hour infusion) Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered.
DRUG	Cisplatin	cisplatin 50 mg/m2 day 1 and 2 Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered.
DRUG	Gemcitabine	gemcitabine 1000mg/m2 days 1 and 8 (in a 30 minute infusion) Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-02-01
• Completion: 2016-10-01
• First posted: 2007-09-19
• Last updated: 2017-10-03

Locations

1 site across 1 country: Denmark