· The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to progression free survival in patients with germ cell tumours previously treated with BEP.
Conditions
Interventions
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: CISPLATIN
CAS Number: 15663271
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 100-
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: · Histologically confirmed germ cell tumor (seminoma or non-seminoma) with measurable metastatic disease either by radiography (at a site which has previously not been irradiated) or elevation of alpha fetoprotein (AFP) and/or elevation of beta-human chorionic gonadotropin (beta-HCG); · Patient previously treated with standard BEP (3 or 4 cycles) with relapse 1 months or more after favorable response on previous chemotherapy (CR or PR) · Male · Age greater than or equal to 18 years; · Performance status 0,1,2 or 3 · WBC > 3x109/l, ANC > 1,5x109/l, platelet count > 100x109/l; serum bilirubin ?60 ml/min). GFR will be assessed by direct measurement (EDTA clearance or creatinine clearance) · signed informed consent; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Uncontrolled active severe clinical infection (CTC grade 3 or 4). · Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), including expected difficulty of follow-up related to mental disorders. · Grade 2 or greater peripheral neuropathy according to the CTC, version 3.0. · Second malignancy other than basal or squamous cell skin cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: · The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to progression free survival in patients with germ cell tumours previously treated with BEP. · To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP ;Secondary Objective: · Overall survival · Response rates (RECIST) · Duration of response ;Primary end point(s): · The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to progression free survival in patients with germ cell tumours previously treated with BEP. | — |
Countries
Denmark, Netherlands
Outcome results
None listed