Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas

NCT01426633 | Completed Phase 1

• 1 other identifier: GISG-02
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Leiomyosarcoma; Liposarcoma

Keywords

L-sarcomas

Outcome Measures

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.

  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.

  12 months

Study Arms (1)

Gemcitabine + Trabectedin

EXPERIMENTAL

Drug: Gemcitabine + Trabectedin

Interventions

Gemcitabine + Trabectedin DRUG

Combination therapy of gemcitabine and trabectedin

Gemcitabine + Trabectedin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Mannheim University Medical Center

Mannheim, 68167, Germany

Location

Related Publications (1)

• Kasper B, Reichardt P, Pink D, Sommer M, Mathew M, Rauch G, Hohenberger P. Combination of trabectedin and gemcitabine for advanced soft tissue sarcomas: results of a phase I dose escalating trial of the German Interdisciplinary Sarcoma Group (GISG). Mar Drugs. 2015 Jan 13;13(1):379-88. doi: 10.3390/md13010379.

  PMID: 25591040 DERIVED

MeSH Terms

Conditions

Leiomyosarcoma; Liposarcoma

Interventions

Gemcitabine; Trabectedin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Dioxoles; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bernd Kasper, MD, PhD

  University of Heidelberg, Mannheim University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: August 29, 2011
• First Posted: August 31, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

DE (1)