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
not relevant
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
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.
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.
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
Department of Oncology 5073, Rigshospitalet
Copenhagen, Denmark
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. · ·
Time frame: December 2010
Secondary Objectives · Overall survival
Time frame: 5 years
Secondary Objectives · Progression free survival
Time frame: 5 years
Secondary Objectives · Response rates (RECIST)
Time frame: 5 years
Secondary Objectives · Duration of response
Time frame: 5 years
Secondary Objectives · To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP
Time frame: 5 years
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