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

• Status: Terminated
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Gemcitabine; Paclitaxel

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 > 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.