Study on Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Treating Leiomyosarcoma

Sponsor: Sarcoma Oncology Research Center, LLC

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04535271

Provider View

This clinical trial is testing a combination of three drugs—trabectedin, gemcitabine, and dacarbazine—given in specific doses to see if they can effectively treat leiomyosarcoma, a type of cancer. The study involves 80 patients receiving these drugs through an IV every three weeks.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of a combination of three drugs—trabectedin, gemcitabine, and dacarbazine—given in specific doses to treat leiomyosarcoma, a type of cancer. The treatment is administered through an IV every three weeks, and patients can continue receiving it for up to a year unless the cancer progresses significantly or side effects become too severe.

Description

This study involves 80 patients who will receive a combination of three drugs: trabectedin, gemcitabine, and dacarbazine. These drugs are given in specific doses through an IV on the first and eighth days of each three-week cycle. Patients can continue the treatment for up to a year unless their cancer worsens significantly or they experience unacceptable side effects. If a patient withdraws or does not complete the first two treatment cycles and the initial follow-up scan, they will be replaced in the study.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced or metastatic leiomyosarcoma that cannot be surgically removed.
  • Have previously received treatment and have measurable disease.
  • Be in relatively good health with an ECOG performance status of 0 to 2.
  • Have a life expectancy of at least 3 months.
  • Have acceptable liver function, with specific limits on bilirubin and liver enzymes.
  • Have acceptable kidney function, with creatinine levels within specified limits.
  • Have adequate blood cell counts, including neutrophils, platelets, and hemoglobin.
  • Have normal blood clotting times unless on anticoagulants, in which case levels must be within therapeutic range.
  • Be able to understand the study and sign a consent form.
  • Be willing to follow all study procedures and be available for the study duration.
  • Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during the study and for 5 months after the last dose. Men must agree to use contraception for 7 months after the last dose.

Exclusion Criteria

  • Currently participating in another clinical trial or have recently finished another trial within the last 14 days.
  • Have known allergies to trabectedin, gemcitabine, or dacarbazine.
  • Women who are pregnant, breastfeeding, or planning to become pregnant during the study and for 3 months after the last dose.
  • Women of childbearing potential who are unwilling to use effective contraception during the study and for 3 months after the last dose.
  • Sexually active participants and their partners who are unwilling to use condoms.

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