Testicular Cancer
Conditions
Keywords
relapse
Brief 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
Detailed description
not relevant
Interventions
DRUGPaclitaxel
Paclitaxel 175 mg/m2 day 1 (3 hour infusion) Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered.
DRUGCisplatin
cisplatin 50 mg/m2 day 1 and 2 Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered.
DRUGGemcitabine
gemcitabine 1000mg/m2 days 1 and 8 (in a 30 minute infusion) Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. · · | December 2010 |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives · Overall survival | 5 years |
| Secondary Objectives · Progression free survival | 5 years |
| Secondary Objectives · Response rates (RECIST) | 5 years |
| Secondary Objectives · Duration of response | 5 years |
| Secondary Objectives · To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP | 5 years |
Countries
Denmark
Outcome results
None listed