New combo therapy targets rare abdominal cancer before surgery
NCT ID NCT03361436
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests the safety and best dose of the chemotherapy drug eribulin when given with radiation therapy before surgery for retroperitoneal liposarcoma, a rare cancer that grows in the abdomen. About 15 patients will receive the combination to see how well they tolerate it and whether it helps shrink tumors before surgical removal. The goal is to find a tolerable dose for future studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Eribulin mesylate (chemotherapy drug)
- What this could lead to
- If successful, this could lead to a new treatment option that shrinks tumors before surgery, potentially improving outcomes for people with this rare cancer.
- What could go wrong
- This is a very early, small trial (Phase 1, only 15 people) focused on safety and dosing. It may not show clear benefit, and side effects from combining chemotherapy and radiation could be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
15 people
The number who actually took part.
- Started
-
Mar 2018
- Expected to finish
-
Apr 2033
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pathologically confirmed diagnosis of liposarcoma; all subtypes are eligible * Sufficient archival tissue available for correlative studies; submission of formalin-fixed paraffin-embedded (FFPE) tumor tissue from a previous biopsy or resection is required, and the most recent specimen is preferred; if a FFPE block cannot be provided, then 10 unstained, positively-charged slides of 4-5 um thickness must be submitted; if insufficient archival tissue is available, a repeat biopsy will be necessary * Primary or recurrent retroperitoneal, scrotal/spermatic cord or abdominal tumor * For subjects between the ages of 12-18 years only, body surface area (BSA) must be \>= 1.5 m\^2 * All sites of disease must be resectable or borderline resectable as assessed by a surgical oncologist with experience in retroperitoneal sarcoma resection after discussion in our institutional multidisciplinary sarcoma tumor board conference * All sites of disease must be targetable with intensity-modulated radiation therapy (IMRT) with acceptable morbidity and without exceeding normal tissue dose constraints as assessed by a radiation oncologist * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening * Fridericia's correction formula (QTcF) interval on standard 12-lead electrocardiography (ECG) parameters at screening (defined as the mean of the triplicate ECGs) of \< 450 msec for males and \< 470 msec for females * Ejection fraction of \>= 50% * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%) * Individuals of childbearing potential must be willing to use adequate contraception throughout the study and for 3 weeks after study drug discontinuation * Absolute neutrophil count (ANC) \>= 1 K/cu mm * Platelets (no transfusion within prior 7 days) \>= 100 K/cu mm * Hemoglobin (no transfusion within prior 7 days) \>= 9.0 g/dL * Total bilirubin \< institutional upper limit of normal (ULN), except for subjects with documented Gilbert's syndrome, for which =\< 3.0 x ULN or direct bilirubin =\< 1.5 x ULN * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN * Estimated creatinine clearance \> 50 mL/min by Cockcroft-Gault equation * Ability to understand and the willingness to sign a written informed consent document; subject has signed the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements Exclusion Criteria: * Presence of distant metastases; intra-abdominal (regional) spread is allowable if meets inclusion criterial indeterminate or small volume pulmonary nodules may be eligible, if the treating physicians recommend curative-intent resection of the primary tumor despite the presence of possible lung metastases * Prior radiation or systemic therapy for the diagnosis of liposarcoma * Prior eribulin * Grade \>= 2 peripheral neuropathy * Contraindication to magnetic resonance imaging (MRI), including presence of a pacemaker or aneurysm clip, severe claustrophobia, a known reaction to gadolinium contrast, or body weight exceeding 300 pounds (lbs) * Concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of malignancies that have completed therapy and are considered by their physician to be at less than 30% risk of relapse; prior systemic therapy is allowed with the exception of prior eribulin; prior radiation therapy is allowed with the exception of any abdominal, pelvic or retroperitoneal radiation \> 10 Gy * History of uncontrolled arrhythmia, congenital long QT syndrome or torsades de pointes (TdP) * Use of more than one medication with a known risk of TdP * Major operation within 14 days prior to starting study drug or not recovered from surgical complications; neither tumor biopsy nor central line insertion are considered a major operation * Active infection; any systemic antimicrobial therapy must be completed \>= 5 days prior to initiation of protocol therapy * Pregnant or nursing (lactating) individuals; NOTE: Pregnant individuals are excluded from this study because eribulin is an investigational agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the individual with eribulin breastfeeding should be discontinued; these potential risks may also apply to doxorubicin * Unable or unwilling to stop the use of herbal supplements; the use of marijuana or its derivatives is allowed; the use of supplements may be allowed after review by a study pharmacist to confirm no significant risk of interaction with eribulin or radiation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
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