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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Leiomyosarcoma, Liposarcoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Bernd Kasper, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Heidelberg, Mannheim University Medical Center

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

GISG-02

NCT ID:

NCT01426633

Start Date:

November 2011

Completion Date:

Related Keywords:

  • Leiomyosarcoma
  • Liposarcoma
  • L-sarcomas
  • Leiomyosarcoma
  • Liposarcoma

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