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

February 13, 2009 updated by: University Hospital Tuebingen

Randomized Phase II-Trial to Determine the Impact of Darbepoetin Alfa on the Frequency of RBC Transfusions in Patients With Metastatic "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP Regimen)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • Medical Center II, University of Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
frequency of transfusions (reduction from 90% to 65%)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Joerg T. Hartmann, MD, South West German Cancer Center, Medical Center II, University of Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

February 16, 2009

Last Update Submitted That Met QC Criteria

February 13, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • jth_004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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