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Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas

Primary Purpose

Leiomyosarcoma, Liposarcoma

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Gemcitabine + Trabectedin
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leiomyosarcoma focused on measuring L-sarcomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mannheim University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine + Trabectedin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 29, 2011
Last Updated
December 15, 2014
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT01426633
Brief Title
Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyosarcoma, Liposarcoma
Keywords
L-sarcomas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine + Trabectedin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gemcitabine + Trabectedin
Intervention Description
Combination therapy of gemcitabine and trabectedin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Kasper, MD, PhD
Organizational Affiliation
University of Heidelberg, Mannheim University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mannheim University Medical Center
City
Mannheim
ZIP/Postal Code
68167
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25591040
Citation
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.
Results Reference
derived

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Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas

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