Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma

Launched by SARCOMA ONCOLOGY RESEARCH CENTER, LLC · Aug 27, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a combination of three medications—trabectedin, gemcitabine, and dacarbazine—to see how effective they are in treating leiomyosarcoma, a type of cancer that can be advanced and difficult to treat. The trial is open to adult men and women aged 18 and older who have been diagnosed with locally advanced, unresectable, or metastatic leiomyosarcoma and have measurable disease. Participants should also be in decent health overall, with a life expectancy of at least three months, and should not be currently receiving other investigational treatments.

If you decide to participate, you will receive these medications through an intravenous (IV) infusion, and the study will monitor your health closely. It’s important to know that you would need to follow some safety guidelines, such as using effective contraception if you are of childbearing age. The trial is currently recruiting participants, so if you or someone you know meets the eligibility criteria and is interested in exploring this treatment option, it might be worth discussing with a healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or Female ≥ 18 years of age
• • Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic leiomyosarcoma
• • Previously treated patient with measurable disease by RECIST v1.1
• • ECOG performance status ≤ 2
• • Life expectancy of at least 3 months
• • Acceptable liver function: Bilirubin \< 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level \< 3.0 ULN); AST (SGOT), ALT (SGPT) and alk phos \< 2.5 x ULN (\< 5 x ULN if liver metastases present)
• • Acceptable renal function: Creatinine \< 1.5 times ULN and creatinine clearance \> 60 ml/min using the Crockroft-Gault formula
• • Acceptable hematologic status: ANC \>1000 cells/μL; Platelet count \>100,000/μL; Hemoglobin \> 9.0 g/dL
• • INR and PT \< 1.5 ULN unless taking anti-coagulation, in which case PT, INR and aPTT must be within therapeutic range of intended use of anticoagulants
• • Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the Investigator's IRB/Ethics Committee
• • Willingness to comply with all study procedures and availability for the duration of the study
• • All women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours of enrollment. If urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.
• Exclusion Criteria:
• • Currently receiving treatment with another investigational device or drug study, or \<14 days since ending treatment with another investigational device or drug study(s).
• • Subject has known sensitivity to trabectedin, gemcitabine or dacarbazine.
• • Female subject is pregnant or breast-feeding or planning to become pregnant during study treatment and through 3 months after the last dose of trabectedin, gemcitabine or dacarbazine.
• • Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of trabectedin, gemcitabine or dacarbazine.
• • Sexually active subjects and their partners unwilling to use male or female latex condom