Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01426633

Enrollment

Registered

2011-08-31

Start date

2011-11-30

Completion date

2014-12-31

Last updated

2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leiomyosarcoma, Liposarcoma

Keywords

L-sarcomas

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.

Interventions

DRUGGemcitabine + Trabectedin

Combination therapy of gemcitabine and trabectedin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026