Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01426633
Recruitment Status : Completed
First Posted : August 31, 2011
Last Update Posted : December 16, 2014
Information provided by (Responsible Party):
Bernd Kasper, Heidelberg University

Brief 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.

Condition or disease Intervention/treatment Phase
Leiomyosarcoma Liposarcoma Drug: Gemcitabine + Trabectedin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Gemcitabine + Trabectedin Drug: Gemcitabine + Trabectedin
Combination therapy of gemcitabine and trabectedin

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01426633

Mannheim University Medical Center
Mannheim, Germany, 68167
Sponsors and Collaborators
Heidelberg University
Principal Investigator: Bernd Kasper, MD, PhD University of Heidelberg, Mannheim University Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bernd Kasper, PD Dr. med., Heidelberg University Identifier: NCT01426633     History of Changes
Other Study ID Numbers: GISG-02
First Posted: August 31, 2011    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014

Keywords provided by Bernd Kasper, Heidelberg University:

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Adipose Tissue
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents