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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01426633
Other study ID # GISG-02
Secondary ID
Status Completed
Phase Phase 1
First received August 29, 2011
Last updated December 15, 2014
Start date November 2011
Est. completion date December 2014

Study information

Verified date December 2014
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Gemcitabine + Trabectedin
Combination therapy of gemcitabine and trabectedin

Locations

Country Name City State
Germany Mannheim University Medical Center Mannheim

Sponsors (1)

Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
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