Actively Recruiting
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
Led by University of Colorado, Denver · Updated on 2026-02-05
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
C
Cancer League of Colorado
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign informed consent and follow all study procedures
- Male or female aged 65 to 100 years
- Diagnosed with advanced or metastatic soft tissue leiomyosarcoma not treatable by surgery
- Measurable or evaluable disease per cancer response criteria
- Received 0 to 4 prior systemic treatments for metastatic sarcoma but no prior anthracycline chemotherapy
- Adequate organ function
- ECOG performance status of 0, 1, or 2
- Willing to undergo tumor biopsies at baseline and during treatment
- Male participants agree to use contraception during and 120 days after treatment
- Female participants are post-menopausal or have had hysterectomy or bilateral oophorectomy
- Have or agree to placement of a central venous catheter
You will not qualify if you...
- Prior treatment with anthracycline chemotherapy
- Allergy or hypersensitivity to doxorubicin or its ingredients
- Receiving other investigational drugs within 28 days before study start
- Recent chemotherapy, targeted therapy, or radiation within 21 days before study or not recovered from side effects
- Active progressing malignancy other than certain skin cancers or in situ cervical cancer
- Known immune deficiencies, chronic infections like hepatitis, HIV, or tuberculosis
- Blood clotting disorders or recent serious bleeding events
- Active brain metastases or carcinomatous meningitis
- Live vaccine received within 30 days before study
- Uncontrolled illnesses including active infections or serious heart conditions
- Prolonged QTc interval on EKG greater than 475 ms
- Reduced heart function with ejection fraction below 50%
- Serious medical or psychiatric conditions affecting study participation including advanced heart disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
C
Chelsey Cartwright
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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