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

Phase 2

Terminated

• Conditions: Testicular Cancer
• Interventions: Drug: Paclitaxel; Drug: Cisplatin; Drug: Gemcitabine

• Registration Number: NCT00531687
• Lead Sponsor: Rigshospitalet, Denmark

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

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-18
• Study First Submitted QC: 2007-09-18
• Study First Posted: 2007-09-19
• Primary Completion: 2012-02
• Study Completion: 2016-10
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-29
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GCT	Paclitaxel	cisplatin Paclitaxel gemcitabine
GCT	Gemcitabine	cisplatin Paclitaxel gemcitabine
GCT	Cisplatin	cisplatin Paclitaxel gemcitabine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Oncology 5073, Rigshospitalet; 🇩🇰 Copenhagen, Denmark