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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

Must not have

Prior radiation or systemic therapy for the diagnosis of liposarcoma

Prior eribulin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatment for liposarcoma before.

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I have previously been treated with eribulin.

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I am taking more than one medication known to increase the risk of a specific heart rhythm problem.

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I am not pregnant or nursing.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

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I do not have a history of uncontrolled heart rhythm problems.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 10 weeks of radiation, until study completion (up to 4 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limiting toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03

Secondary study objectives

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

+6 more

Side effects data

From 2013 Phase 3 trial • 637 Patients • NCT00884741

30%

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%

Wound dehiscence

10%

Vascular access complication

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%

Study treatment Arm

Pre-Randomization TMZ+RT

Randomized Arm 1: TMZ+RT + Placebo

Randomized Arm 2: TMZ+RT + Bevacizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~9890

Eribulin Mesylate

2014

Completed Phase 4

~3420