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Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas

NCT01426633 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2014-12-16

No results posted yet for this study

Summary

L-sarcomas represent about one third of all adult soft tissue sarcomas (24 % liposarcomas and 12 % leiomyosarcomas). Approval for the induction of trabectedin into the treatment armamentarium of advanced and/or metastatic soft tissue sarcomas after treatment failure with anthracyclines and/or ifosfamide depended mainly on its activity in the L-sarcomas (Garcia-Carbonero 2004, Le Cesne 2005, and Demetri 2009). Significant activity has been described for the use of gemcitabine and especially the combination of gemcitabine and docetaxel mainly in leiomyosarcomas and liposarcomas (Maki 2007). However, the combination of gemcitabine and docetaxel is associated with significant toxicity. Pulmonary toxicity and refractory peripheral oedema are the most common severe adverse events. The aim of the present phase I study will be to examine safety data of this promising treatment combination of gemcitabine and trabectedin in L-sarcomas.

Conditions

  • Leiomyosarcoma
  • Liposarcoma

Interventions

DRUG

Gemcitabine + Trabectedin

Combination therapy of gemcitabine and trabectedin

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Bernd Kasper, MD, PhD · University of Heidelberg, Mannheim University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01426633 on ClinicalTrials.gov