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 (May 2026). This Phase 2 trial studies Doxorubicin for sarcoma.

Phase 2RecruitingUniversity of Colorado, DenverNCT07125183Data as of May 2026

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.

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Extracted eligibility criteria

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)

Prior therapy

Max 4 prior lines

Min 0 prior lines

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

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