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Eribulin + Radiation for Abdominal Cancer
Phase 1
Waitlist Available
Led By Lara E Davis
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically confirmed diagnosis of liposarcoma; all subtypes are eligible
Primary or recurrent retroperitoneal, scrotal/spermatic cord or abdominal tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of a chemotherapy drug called eribulin mesylate, when given together with radiation therapy, in treating patients with retroperitoneal liposarcoma.
Who is the study for?
This trial is for patients with a specific cancer called retroperitoneal liposarcoma that can be surgically removed. Eligible participants include those with measurable disease, good performance status, adequate organ function, and no prior treatment for this cancer type. They must also agree to use contraception and have no history of certain heart conditions or other cancers within the last 3 years.Check my eligibility
What is being tested?
The trial is testing the combination of eribulin mesylate (a chemotherapy drug) with radiation therapy to see how well they work together in treating retroperitoneal liposarcoma. The study will determine the best dose of eribulin when used alongside high-energy x-rays intended to kill tumor cells.See study design
What are the potential side effects?
Potential side effects may include reactions typical of chemotherapy such as fatigue, nausea, hair loss, increased risk of infection due to low blood cell counts, neuropathy (nerve pain or tingling), and potential damage at the site where radiation is delivered.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with liposarcoma.
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My cancer is located in the abdomen, scrotum, or behind the stomach.
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I am 12-18 years old with a body surface area of at least 1.5 m^2.
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My cancer can be targeted with a specific radiation therapy without harming healthy tissues, as confirmed by a specialist.
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My heart pumps blood well.
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I am mostly active and can care for myself.
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My kidneys are functioning well, with a creatinine clearance over 50 mL/min.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 10 weeks of radiation, until study completion (up to 4 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 10 weeks of radiation, until study completion (up to 4 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03
Secondary outcome measures
Change in subject-reported quality of life assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)
Objective response rate (ORR) defined as the proportion of subjects who achieved a complete response (disappearance of all target tumors) or a partial response (>= 30% decrease in the sum of the longest diameters of target tumors)
Overall survival rate
+7 moreSide effects data
From 2013 Phase 3 trial • 637 Patients • NCT0088474130%
Fatigue
20%
Thrombosis
20%
Nausea
20%
Hemoglobin decreased
20%
Lymphopenia
20%
Alanine aminotransferase increased
20%
Hyperglycemia
20%
Hyponatremia
20%
Seizure
10%
Alopecia
10%
Weight loss
10%
Opportunistic infection
10%
Dry mouth
10%
Wound infection [with normal or Grade 1-2 ANC]
10%
Wound infection [with unknown ANC]
10%
Vascular access complication
10%
Wound dehiscence
10%
Dysphagia
10%
Acoustic nerve disorder NOS
10%
Anorexia
10%
Dehydration
10%
Eye disorder
10%
Disease progression
10%
Headache
10%
Hearing loss
10%
Tinnitus
10%
Fracture
10%
Creatinine increased
10%
Hyperkalemia
10%
Hypermagnesemia
10%
Hypoalbuminemia
10%
Muscle weakness left-sided
10%
Memory impairment
10%
Neurological disorder NOS
10%
Taste alteration
10%
Depression
10%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pre-Randomization TMZ+RT
Randomized Arm 1: TMZ+RT + Placebo
Randomized Arm 2: TMZ+RT + Bevacizumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (eribulin mesylate, IMRT, surgery)Experimental Treatment6 Interventions
Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8 and undergo intensity-modulated radiation therapy QD 5 days a week beginning on day 8 of cycle 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo surgery within 3-10 weeks after radiation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Eribulin Mesylate
2014
Completed Phase 4
~3420
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Find a Location
Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,711 Total Patients Enrolled
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
154,005 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
6,846,014 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had treatment for liposarcoma before.I have been diagnosed with liposarcoma.I have previously been treated with eribulin.I cannot have an MRI due to a pacemaker, severe claustrophobia, allergy to contrast dye, or weighing over 300 lbs.My heart pumps blood well.I am mostly active and can care for myself.My kidneys are functioning well, with a creatinine clearance over 50 mL/min.I understand the study and agree to participate by signing the consent form.My cancer is located in the abdomen, scrotum, or behind the stomach.I have no active infections and haven't taken antibiotics in the last 5 days.I haven't had cancer or cancer treatment in the last 3 years, except for low-risk cases.I cannot or will not stop taking herbal supplements, but I'm okay with a review for safety.My cancer, located in the area behind my abdomen, is considered operable by a specialist.I am taking more than one medication known to increase the risk of a specific heart rhythm problem.I haven't had major surgery or recovered from one in the last 2 weeks.I can provide tissue samples from a previous surgery or biopsy for study.I am not pregnant or nursing.I am 12-18 years old with a body surface area of at least 1.5 m^2.My cancer can be targeted with a specific radiation therapy without harming healthy tissues, as confirmed by a specialist.I have moderate to severe numbness, tingling, or pain in my hands or feet.My bilirubin levels are within the normal range, or I have Gilbert's syndrome with specific levels.My cancer has spread, but surgery might still be an option for me.I do not have a history of uncontrolled heart rhythm problems.My hemoglobin level is at least 9.0 g/dL without recent transfusions.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (eribulin mesylate, IMRT, surgery)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Intensity-Modulated Radiation Therapy been granted regulatory acceptance?
"The safety of Intensity-Modulated Radiation Therapy was assessed by the team at Power and given a score of 1, since this is an early stage trial with limited data supporting effectiveness or safety."
Answered by AI
How many participants are being monitored during this trial?
"Affirmative. Clinicaltrials.gov's records indicate that this medical research is actively enrolling patients, with a post date of March 19th 2018 and an update on October 17th 2022. The team behind the trial are currently seeking 16 individuals at one centre in particular."
Answered by AI
What other investigative efforts have been undertaken regarding Intensity-Modulated Radiation Therapy?
"At the current moment, 37 clinical trials have been initiated to study Intensity-Modulated Radiation Therapy. Of these active studies, 10 are in Phase 3. Although most of the research is occurring in Seoul and Florida, a remarkable 1225 locations are running investigations into this therapeutic option."
Answered by AI
Are there currently opportunities to enroll in this clinical research?
"According to the clinicaltrials.gov platform, this trial is currently enrolling participants and has been doing so since its inception on March 19th 2018 with a most recent update occurring on October 17th 2022."
Answered by AI
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