SarcomaPhase 2NCT07125183
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
A Phase 2 study testing Doxorubicin in people with Sarcoma, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Be male or female aged 65-100 years at the time of signing informed consent.
- Have a histological diagnosis of advanced or metastatic soft tissue leiomyosarcoma (LMS) (by local pathology review), not curable by surgery, for which treatment with weekly doxorubicin is deemed appropriate by the investigator.
- Have measurable or non-measurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors. Tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is documented, or a biopsy is obtained to confirm persistence at least 90 days following completion of radiotherapy.
- Have received 0 to 4 prior systemic therapies for metastatic sarcoma and NO prior anthracyclines. Re-treatment with the same drug or regimen after interruption (i.e. chemotherapy holiday) is not considered a new line of treatment, and those patients are eligible.
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- Adequate organ function
- ECOG performance status of 0, 1 or 2.
- Patients must consent and be willing to undergo tumor core needle biopsies at two time points: 1. Baseline, 2. Cycle 2 Day 1 (+/- 7 days); a third biopsy for off-study/progression is optional but advised. At least one tumor site must be amenable to biopsy in the judgment of the interventional radiologist and/or inverstigator.
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Prior history of vasectomy does NOT replace requirement for contraceptive use.
- Female subjects will be post-menopausal as evidenced by cessation of menses for a minimum of 2 years. Prior hysterectomy or bilateral oophorectomy is also permissible.
- Subjects must either possess or undergo placement of central venous catheter, including pheresis or trifusion catheter, PICC line, or port.
Who cannot join
- Prior therapy with anthracycline.
- Hypersensitivity to doxorubicin or any excipients.
- Patients may not be receiving any other investigational agents (within 28 days prior to Cycle 1, Day 1).
- Patient has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 21 days prior to Cycle 1, Day 1 or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 21 days earlier. Subjects with ≤ Grade 2 neuropathy or alopecia are an exception to this criterion and may qualify for the study.
- Note: If a subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Additional known malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
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- Patients with underlying immune deficiency, chronic infections including hepatitis, and known history of HIV or tuberculosis (TB).
- Patients with underlying hematologic issues including bleeding diathesis, such as known previous GI bleeding requiring intervention within the past 6 months. Newly diagnosed pulmonary emboli or deep venous thrombosis must be clinically stable on anticoagulation regimen for ≥ 2 weeks as of Cycle 1 Day 1.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease. Subjects with previously treated brain metastases may participate provided they are stable based on the following: 1) MRI brain obtained during screening evaluations shows no radiographic evidence of progression or new lesions, 2) any neurologic symptoms have returned to baseline. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. Patients without a known history of brain metastases do not require screening brain MRI prior to study enrollment.
- Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- Any uncontrolled, intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
- Prolonged QTc interval on Screening EKG >475 ms.
- Left Ventricular Ejection Fraction <50% by 2D ECHO or MUGA scan at Screening.
- Any serious medical or psychiatric illness/condition including substance use disorders likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment, including NYHA Class II or greater heart disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Of Colorado Hospital
Aurora, Colorado, 80045
Chelsey Cartwright, 720-848-0741, chelsey.cartwright@cuanschutz.edu
Breelyn Wilky, MD
About this study
Official title: A Phase II Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma of Soft Tissue
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.
Read the detailed description
The study is an open-label, single-arm, investigator-initiated Phase 2 trial enrolling up to 30 patients to obtain 20 evaluable patients with advanced/metastatic leiomyosarcomas. The study will utilize a time-to-event Bayesian optimal Phase 2 design. The design includes one interim futility look after 10 patients are evaluable for progression-free survival rate at 12 weeks. The outcomes will be compared to historical PFS 12 week rate calculated as the mean from two large randomized Phase 3 studies. The treatment will be deemed promising if the number of patients who are stable at 12 weeks is 65%. Early stopping rules for toxicity are included in addition to futility.
The primary endpoint of the study is the PFS rate at 12 weeks with secondary endpoints including PFS at 6 months, response rate by RECIST 1.1, duration of response, overall survival, adverse events, and quality of life scores. Correlative studies will include analysis of serial blood samples and baseline and on-treatment tumor biopsies for immune markers including analysis of tumor-infiltrating lymphocytes, tumor immune pathways, analysis of circulating immune cells, and plasma cytokines.
Following informed consent and screening, patients will receive doxorubicin 25 mg/m2 administered by bolus with dexrazoxane pre-treatment on days 1 and 8 every 21 days for up to 8 cycles. Patients will receive pegfilgrastim growth factor on day 9. Scans for response imaging will be obtained every 6 weeks during the treatment portion of the study, then every 12 weeks after completing treatment up to 1 year. Patients will have routine safety labs, assessment of adverse events, quality of life questionnaires with treatment visits, and echocardiogram to assess for cardiac toxicity will be performed at cycle 4 of doxorubicin and at the completion of study therapy.
- Conditions
- Sarcoma
- Being tested
- Doxorubicin
- Keywords
- Metastatic Sarcoma, Advanced Sarcoma, leiomyosarcoma, doxorubicin, geriatric
- Medical subject headings
- Sarcoma, Leiomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Also called Lipodox, Lipodox 50, Doxil
Doxorubicin is an antibiotic derived from the Streptomyces peucetius bacterium. It has widespread use as a chemotherapeutic agent since the 1960s. Doxorubicin is part of the anthracycline group of chemotherapeutic agents. Doxorubicin may be used to treat soft tissue and bone sarcomas and cancers of the breast, ovary, bladder, and thyroid. It is also used to treat acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, and small cell lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| Doxorubicin | Experimental | Doxorubicin will be administered on days 1 and 8 every 21 days for a maximum of 8 cycles (Cycles 1-8) with appropriate premedications and pegfilgrastim growth factor support. Doxorubicin will be administered as a bolus infusion on day 1 and day 8 with dexrazoxane cardioprotection. Patients must have central line access for this protocol, including pheresis or trifusion catheter, PICC line, or port. Receives: Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the efficacy of treatment measured by Progression Free Survival (PFS) rate at 12 weeks
weekly doxorubicin chemotherapy in anthracycline-naïve patients measured through PFS at 12 weeks by RECIST 1.1
Measured: 12 weeks
Secondary outcomes (8)
Progression Free Survival rate at 6 months
Rate of patients that are progression-free at the 6 month timepoint by RECIST 1.1
Measured: 6 month
Quality of Life (QoL) by EORTC-QLQ-30
Patients will complete questionnaires to assess clinical benefit. The assessment will be based on a scale of strongly agree to strongly disagree.
Measured: 6 months
Quality of Life by QLQ-ELD14
Patients will complete questionnaires to assess clinical benefit. The assessment will be based on a scale of strongly agree to strongly disagree.
Measured: 6 months
Response rate measured by RECIST 1.1
Response rate by RECIST 1.1. Scans will be obtained every 6 weeks while on study therapy.
Measured: 18 months
Duration of Response
Time that patients achieve a partial or complete response until progression by RECIST 1.1.
Measured: 18 months
Overall Survival
Length of time from study enrollment to death by any cause.
Measured: 18 months
Proportion of Doxorubicin Doses administered.
Evaluable patients will receive at least one dose of doxorubicin. We will determine the proportion of doses administered according to the study protocol, that are not omitted due to toxicity.
Measured: 6 months
Toxicity Assessed by Adverse Events
Adverse events will be assessed using CTCAE version 5.0.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer League of Colorado
- Responsible party
- Sponsor
- Investigators
- Breelyn Wilky, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125183
- Sponsor's protocol ID
- 24-0118.cc
- Other IDs
- NCI-2025-05219
- Status last verified
- Feb 2026
- First submitted
- 18 Jul 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma of Soft Tissue
- ClinicalTrials.gov ID
- NCT07125183
- Acronym / sponsor ID
- 24-0118.cc
- Conditions
- Sarcoma
- Keywords
- Metastatic Sarcoma, Advanced Sarcoma, leiomyosarcoma, doxorubicin, geriatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Cancer League of Colorado
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is an open-label, single-arm, investigator-initiated Phase 2 trial enrolling up to 30 patients to obtain 20 evaluable patients with advanced/metastatic leiomyosarcomas. The study will utilize a time-to-event Bayesian optimal Phase 2 design. The design includes one interim futility look after 10 patients are evaluable for progression-free survival rate at 12 weeks. The outcomes will be compared to historical PFS 12 week rate calculated as the mean from two large randomized Phase 3 studies. The treatment will be deemed promising if the number of patients who are stable at 12 weeks is 65%. Early stopping rules for toxicity are included in addition to futility.
The primary endpoint of the study is the PFS rate at 12 weeks with secondary endpoints including PFS at 6 months, response rate by RECIST 1.1, duration of response, overall survival, adverse events, and quality of life scores. Correlative studies will include analysis of serial blood samples and baseline and on-treatment tumor biopsies for immune markers including analysis of tumor-infiltrating lymphocytes, tumor immune pathways, analysis of circulating immune cells, and plasma cytokines.
Following informed consent and screening, patients will receive doxorubicin 25 mg/m2 administered by bolus with dexrazoxane pre-treatment on days 1 and 8 every 21 days for up to 8 cycles. Patients will receive pegfilgrastim growth factor on day 9. Scans for response imaging will be obtained every 6 weeks during the treatment portion of the study, then every 12 weeks after completing treatment up to 1 year. Patients will have routine safety labs, assessment of adverse events, quality of life questionnaires with treatment visits, and echocardiogram to assess for cardiac toxicity will be performed at cycle 4 of doxorubicin and at the completion of study therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doxorubicin | Experimental | Drug: DoxorubicinDoxorubicin will be administered on days 1 and 8 every 21 days for a maximum of 8 cycles (Cycles 1-8) with appropriate premedications and pegfilgrastim growth factor support. Doxorubicin will be administered as a bolus infusion on day 1 and day 8 with dexrazoxane cardioprotection. Patients must have central line access for this protocol, including pheresis or trifusion catheter, PICC line, or port. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Be male or female aged 65-100 years at the time of signing informed consent.
- Have a histological diagnosis of advanced or metastatic soft tissue leiomyosarcoma (LMS) (by local pathology review), not curable by surgery, for which treatment with weekly doxorubicin is deemed appropriate by the investigator.
- Have measurable or non-measurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors. Tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is documented, or a biopsy is obtained to confirm persistence at least 90 days following completion of radiotherapy.
Key exclusion criteria (14 listed)
- Prior therapy with anthracycline.
- Hypersensitivity to doxorubicin or any excipients.
- Patients may not be receiving any other investigational agents (within 28 days prior to Cycle 1, Day 1).
- Patient has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 21 days prior to Cycle 1, Day 1 or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 21 days earlier. Subjects with ≤ Grade 2 neuropathy or alopecia are an exception to this criterion and may qualify for the study.
- Note: If a subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxorubicinAlso: Lipodox, Lipodox 50, DoxilDoxorubicin is an antibiotic derived from the Streptomyces peucetius bacterium. It has widespread use as a chemotherapeutic agent since the 1960s. Doxorubicin is part of the anthracycline group of chemotherapeutic agents. Doxorubicin may be used to treat soft tissue and bone sarcomas and cancers of the breast, ovary, bladder, and thyroid. It is also used to treat acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, and small cell lung cancer. | Drug | Doxorubicin |
Primary outcome
Determine the efficacy of treatment measured by Progression Free Survival (PFS) rate at 12 weeks
Time frame: 12 weeks
weekly doxorubicin chemotherapy in anthracycline-naïve patients measured through PFS at 12 weeks by RECIST 1.1
8 secondary outcomes
Progression Free Survival rate at 6 months
Time frame: 6 month
Quality of Life (QoL) by EORTC-QLQ-30
Time frame: 6 months
Quality of Life by QLQ-ELD14
Time frame: 6 months
Response rate measured by RECIST 1.1
Time frame: 18 months
Duration of Response
Time frame: 18 months
Overall Survival
Time frame: 18 months
Proportion of Doxorubicin Doses administered.
Time frame: 6 months
Toxicity Assessed by Adverse Events
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Breelyn Wilky, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxorubicin in people with Sarcoma, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chelsey Cartwright (720-848-0741, chelsey.cartwright@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the efficacy of treatment measured by Progression Free Survival (PFS) rate at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.