Status:
COMPLETED
Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas
Lead Sponsor:
Heidelberg University
Conditions:
Leiomyosarcoma
Liposarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 advan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01426633
Start Date
November 1 2011
End Date
December 1 2014
Last Update
December 16 2014
Active Locations (1)
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1
Mannheim University Medical Center
Mannheim, Germany, 68167