PHASE II TRIAL OF PACLITAXEL, GEMCITABINE AND CISPLATIN IN PATIENTS WITH RELAPSING GERM CELL CANCER AFTER FIRST LINE CHEMOTHERAPY - relapse cis-tax-gem

• Conditions: ·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.; MedDRA version: 9.1Level: LLTClassification code 10018204Term: Germ cell cancer NOS

• Registration Number: EUCTR2007-000618-35-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 25

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 < 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;

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

·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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified