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

Testicular Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00531687
• Other study ID #: Relapse testis cancer 2007
• Status: Terminated
• Phase: Phase 2
• First received: September 18, 2007
• Last updated: September 29, 2017
• Start date: September 2007
• Est. completion date: October 2016

Study information

• Verified date: September 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

not relevant

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: October 2016
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Testicular Cancer
• Testicular Neoplasms

Intervention

Drug:
• Paclitaxel
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.
• Cisplatin
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.
• Gemcitabine
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

Locations

Country	Name	City	State
Denmark	Department of Oncology 5073, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary Objectives · Overall survival		5 years
Secondary	Secondary Objectives · Progression free survival		5 years
Secondary	Secondary Objectives · Response rates (RECIST)		5 years
Secondary	Secondary Objectives · Duration of response		5 years
Secondary	Secondary Objectives · To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP		5 years