Study of Weekly Doxorubicin for Advanced Leiomyosarcoma in Older Adults

This study is looking at how well and how safely a lower weekly dose of doxorubicin works for older patients (ages 65-100) with advanced or metastatic leiomyosarcoma (a type of soft tissue cancer) that cannot be removed by surgery. Doxorubicin is a common chemotherapy drug. Researchers want to see if this weekly schedule can still fight the cancer effectively while being easier to tolerate than standard doses. The main goal is to see how many patients' cancer does not grow or spread for at least 12 weeks. The study is currently recruiting patients.

Study design
This is an open-label, single-arm Phase 2 study aiming to enroll up to 30 patients, with 20 evaluable patients. It uses a Bayesian design with an interim review after 10 patients.
What's involved
After signing consent and screening, you would receive doxorubicin by injection on days 1 and 8 every 21 days for up to 8 cycles. You will also have blood tests and tumor biopsies.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures progression-free survival at 12 weeks, with secondary endpoints including progression-free survival at 6 months and overall survival.

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NCT07125183

Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

Recruiting
PHASE2Ages 65+InterventionalTreatment
University of Colorado, Denver
~20 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:Doxorubicin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the efficacy of treatment measured by Progression Free Survival (PFS) rate at 12 weeks
Measured over 12 weeks
Sarcoma
1 sites across 1 states
Colorado1
  • Breelyn Wilky, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

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  • Determine the efficacy of treatment measured by Progression Free Survival (PFS) rate at 12 weeks12 weeks

    weekly doxorubicin chemotherapy in anthracycline-naïve patients measured through PFS at 12 weeks by RECIST 1.1