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

Phase 2
18 Years
70 Years
Not Enrolling
Testicular Cancer

Thank you

Trial Information

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

not relevant

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

- Grade 2 or greater peripheral neuropathy according to the CTC, version 3.0.

- Second malignancy other than basal or squamous cell skin cancer.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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. · ·

Outcome Time Frame:

December 2010

Safety Issue:


Principal Investigator

Gedske Daugaard, MD, DMSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rigshospitalet, Denmark


Denmark: Danish Dataprotection Agency

Study ID:

Relapse testis cancer 2007



Start Date:

September 2007

Completion Date:

February 2012

Related Keywords:

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