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NCT Number: NCT01426633

Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas

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.

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Key information

Conditions

Leiomyosarcoma Liposarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mannheim University Medical Center

Mannheim, 68167, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine + Trabectedin

Drug

Combination therapy of gemcitabine and trabectedin

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

Phase I Dose Escalating Trial Evaluating the Combination of Gemcitabine and Trabectedin in Patients With Advanced and/or Metastatic Leiomyosarcoma or Liposarcoma

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 31, 2011
Registry last updated
Dec 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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