Using metronomic doses of trabectedin, gemcitabine, and dacarbazine for treating leiomyosarcoma
TAGGED: A Phase 2 Study Using Low Dose/Metronomic Trabectedin, Gemcitabine, and Dacarbazine as 2nd/3rd/4th Line Therapy for Advanced Soft Tissue Sarcoma
This study is testing a new combination of three cancer drugs to see if they can help people with advanced leiomyosarcoma feel better and manage their disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sarcoma Oncology Research Center, LLC Academic / other |
| Locations | 1 site (Santa Monica, California) |
| Trial ID | NCT04535271 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed locally advanced or metastatic leiomyosarcoma who have measurable disease and meet specific health criteria.
Not a fit: Patients with resectable leiomyosarcoma or those with significant comorbidities that affect their ability to tolerate treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced leiomyosarcoma.
How similar studies have performed: While this approach is novel in its specific combination and dosing strategy, similar studies have shown promise in treating soft tissue sarcomas with metronomic chemotherapy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Santa Monica, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.