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

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

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 > 3000 mill/l, ANC > 1500 mill/l, platelet count > 100.000 mill/l; serum bilirubin < 1.5 x the upper limit of normal;
• Adequate renal function (Glomerular Filtration Rate (GFR) >60 ml/min). GFR will be assessed by direct measurement (EDTA clearance or creatinine clearance)
• signed informed consent;

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.