Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)

Phase 2

Completed

• Conditions: Dysgerminoma

• Registration Number: NCT00204633
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

The aim is to determine the frequency of RBC transfusion in patients with metastatic "poor prognosis" germ cell tumor during high-dose chemotherapy (HD-VIP, level 6) with or without Darbepoetin alfa

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-13
• Last Update Posted: 2009-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 108

Inclusion Criteria

• Poor prognosis" according IGCCCG-criteria:
• Primary mediastinal tumor
• Gonadal/retroperitoneal germ cell tumor with visceral metastases except of lung
• Poor marker: AFP > 10.000 ng/ml or beta-HCG > 10.000 ng/ml (50.000 IU/l) andd LDH >10 x upper normal limit
• No previous chemotherapy
• Age > 18 years
• Performance-Status: WHO =< 2
• Written informed consent
• Ability to give informed consent

Exclusion Criteria

• Hemolysis
• Hematological disease with insufficient erythropoiesis
• Patients without sufficient treatment of sideropenia, folate deficiency or vitamin B12 deficiency
• Uncontrolled arterial hypertension
• Treatment with rh-Erythropoetin during trial
• Creatinin clearance < 50 ml/min
• Insufficient bone marrow function (WBC count < 3.000/ml or platelets < 100.000/µl)
• Other major symptomatic or uncontrolled illnesses not allowing to complete treatment protocol with the exception of symptoms caused by the primary disease
• Second malignancy, except of completely resected basal cell carcinoma of the skin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
frequency of transfusions (reduction from 90% to 65%)

Secondary Outcome Measures

Name	Time	Method
proportion of patients with no transfusions
developing of hemoglobin levels
objective remission rate
progression-free- and overall-survival (pfs, os)
quality of life

Trial Locations

Locations (1)

Medical Center II, University of Tuebingen; 🇩🇪 Tuebingen, Germany