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Sponsors and Collaborators: |
University Hospital Tuebingen Arbeitsgemeinschaft fur Internistische Onkologie German Sarcoma Group |
Information provided by: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT00427466 |
The aims of this trial are to evaluate the efficacy and tolerability of pemetrexed in patients with metastatic soft tissue sarcoma who have progressed after or during an anthracycline-based chemotherapy and to assess the toxicity profile
Condition | Intervention | Phase |
Sarcoma |
Drug: Pemetrexed |
Phase II |
MedlinePlus related topics: | Soft Tissue Sarcoma |
ChemIDplus related topics: | Pemetrexed disodium Pemetrexed |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Multicenter Phase II Study With Pemetrexed in Patients With Pre-Treated Metastatic Soft Tissue Sarcomas |
Estimated Enrollment: | 28 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | January 2009 |
One therapy cycle takes a total of 3 weeks. On day 1, Pemetrexed is intravenously administered. The dosage is 500 mg/m2 over a period of 10 minutes. A repetition of this procedure is performed on day 22
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joerg T Hartmann, MD | +49 7071 2982125 | joerg.hartmann@med.uni-tuebingen.de |
Contact: Frank Mayer, MD | +49 7071 2980574 | frank.mayer@med.uni-tuebingen.de |
Germany | |||||
Medical Center II, University of Tuebingen | Recruiting | ||||
Tuebingen, Germany, 72076 | |||||
Contact: Joerg T Hartmann, MD +49 7071 2982125 joerg.hartmann@med.uni-tuebingen.de | |||||
Sub-Investigator: Frank Mayer, MD |
University Hospital Tuebingen |
Arbeitsgemeinschaft fur Internistische Onkologie |
German Sarcoma Group |
Principal Investigator: | Joerg T Hartmann, MD | Medical Center II, University of Tuebingen, Germany |
Study ID Numbers: | jth_006 |
First Received: | January 26, 2007 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00427466 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission |
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