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

Rigshospitalet

Status and phase

Terminated

Phase 2

Conditions

Testicular Cancer

Treatments

Drug: Gemcitabine

Drug: Paclitaxel

Drug: Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

Relapse testis cancer 2007

Details and patient eligibility

About

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

Full description

not relevant

Enrollment

8 patients

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.