Clinical trial NCT00531687: Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer
Official title: Phase II Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Testicular Cancer
Keywords: relapse
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-09-19
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: 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. · ·
timeFrame: December 2010
Secondary outcomes:
measure: Secondary Objectives · Overall survival
timeFrame: 5 years
measure: Secondary Objectives · Progression free survival
timeFrame: 5 years
measure: Secondary Objectives · Response rates (RECIST)
timeFrame: 5 years
measure: Secondary Objectives · Duration of response
timeFrame: 5 years
measure: Secondary Objectives · To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP
timeFrame: 5 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Oncology 5073, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Gedske Daugaard, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: