Using metronomic doses of trabectedin, gemcitabine, and dacarbazine for treating leiomyosarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label phase 2 study investigates the efficacy of metronomic doses of trabectedin, gemcitabine, and dacarbazine administered intravenously to patients with locally advanced, unresectable, or metastatic leiomyosarcoma. A total of 80 patients will receive these treatments in a specific dosing schedule over a 3-week cycle, with the possibility of continuing treatment for up to one year unless significant disease progression or unacceptable toxicity occurs. The study aims to evaluate the safety and effectiveness of this combination therapy in managing the disease.

Why it matters

Who can join: the full rules

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

Where it's running

• Sant P Chawla
  Santa Monica, California, United States Recruiting

Study contacts

• Principal investigator: Sant P Chawla, MD — Sarcoma Oncology Research Center, LLC
• Study coordinator: Sant P Chawla, MD
• Email: santchawla@sarcomaoncology.com
• Phone: 3105529999

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.