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Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas

This study is currently recruiting participants.
Verified November 2011 by University of Heidelberg
Sponsor:
Information provided by (Responsible Party):
Bernd Kasper, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01426633
First received: August 29, 2011
Last updated: November 29, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Leiomyosarcoma
Liposarcoma
 Drug: Gemcitabine + Trabectedin
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Dose Escalating Trial Evaluating the Combination of Gemcitabine and Trabectedin in Patients With Advanced and/or Metastatic Leiomyosarcoma or Liposarcoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • To assess the maximum tolerated dose (MTD) of the combination of gemcitabine and trabectedin (Yondelis®) in patients with advanced and/or metastatic leiomyosarcoma and liposarcoma. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the recommended phase II dose (RPTD) of the combination of gemcitabine and trabectedin (Yondelis®) in patients with advanced and/or metastatic leiomyosarcoma and liposarcoma. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: November 2011
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine + Trabectedin Drug: Gemcitabine + Trabectedin
Combination therapy of gemcitabine and trabectedin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically confirmed L-sarcomas (leiomyosarcoma and liposarcoma)
  • Measurable disease according to RECIST 1.1
  • Any treatment line except adjuvant setting: evidence of primary metastatic situation or disease progression within the last 6 months (based on RECIST 1.1) in computed tomography or magnetic resonance imaging
  • Any prior treatment possible
  • Age >= 18 years
  • WHO PS =< 1
  • Effective contraception during study medication and up to 3 months from treatment discontinuation
  • Signed informed consent form

Exclusion Criteria:

  • Surgical intervention < 4 weeks
  • Pregnancy or lactation
  • Known allergic reaction to trabectedin or gemcitabine or one of their components
  • The following laboratory values:

Absolute neutrophil count < 1.5 x 103/mm3 Platelets < 100.000/mm3 Hb < 9 g/dL Serum creatinine >= 2.5 mg/dl SGOT and/or SGPT and/or alkaline phosphatase and/or CPK > 2.5 x ULN Total bilirubin > 1 x ULN except in the case of Gilbert's syndrome

  • Participation in another study (four weeks before and during the study)
  • Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426633

Contacts
Contact: Bernd Kasper, MD, PhD +49-621-383 ext 2580 bernd.kasper@umm.de
Contact: Michaela Sommer +49-621-383 ext 5168 michaela.sommer@umm.de

Locations
Germany
Mannheim University Medical Center Recruiting
Mannheim, Germany, 68167
Principal Investigator: Bernd Kasper, MD, PhD            
Sponsors and Collaborators
University of Heidelberg
Investigators
Principal Investigator: Bernd Kasper, MD, PhD University of Heidelberg, Mannheim University Medical Center
  More Information

No publications provided

Responsible Party: Bernd Kasper, PD Dr. med., University of Heidelberg
ClinicalTrials.gov Identifier: NCT01426633     History of Changes
Other Study ID Numbers: GISG-02
Study First Received: August 29, 2011
Last Updated: November 29, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:
L-sarcomas

Additional relevant MeSH terms:
Leiomyosarcoma
Liposarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Neoplasms, Adipose Tissue
Gemcitabine
Trabectedin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on May 21, 2013