OncoMatch/Clinical Trials/NCT07125183
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
Is NCT07125183 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Doxorubicin for sarcoma.
Treatment: Doxorubicin — The overall goal of this Phase 2 study is to determine the efficacy of a lower dose weekly schedule of doxorubicin in patients with unresectable leiomyosarcomas aged 65-100 years old. While doxorubicin is the standard of care therapy for sarcomas not removable by surgery, older or more frail patients may struggle to tolerate side effects of the treatment including immune cell suppression. Previous studies have suggested that similar anti-tumor activity can be obtained using a lower dose, weekly administration schedule of doxorubicin. In this study, the investigators will determine progression-free survival rate at 12 weeks, with secondary endpoints including quality of life and adverse events in this population. Importantly, doxorubicin can also induce immune stimulatory effects when administered at lower doses, based on animal data. Thus, correlative samples including blood and tumor biopsies will also explore the effects of immune cells and foreignness of the tumor prior to and during treatment in study patients.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Sarcoma
Disease stage
Metastatic disease required
advanced or metastatic soft tissue leiomyosarcoma (LMS) (by local pathology review), not curable by surgery
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: anthracycline
Lab requirements
Blood counts
Adequate organ function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Cardiac function
Prolonged QTc interval on Screening EKG >475 ms excluded. Left Ventricular Ejection Fraction <50% by 2D ECHO or MUGA scan at Screening excluded. NYHA Class II or greater heart disease excluded.
Adequate organ function; Prolonged QTc interval on Screening EKG >475 ms; Left Ventricular Ejection Fraction <50% by 2D ECHO or MUGA scan at Screening; NYHA Class II or greater heart disease
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University Of Colorado Hospital · Aurora, Colorado
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07125183 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anthracycline disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 100 years or younger and at least 65 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages