Eribulin + Radiation for Abdominal Cancer

Recruiting in Palo Alto (17 mi)

Lara Davis - Oregon Health & Science ...

Overseen byLara Davis, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: OHSU Knight Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase Ib trials studies the side effects and best dose of eribulin mesylate when given together with radiation therapy in treating patients with retroperitoneal liposarcoma that can be removed by surgery. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells.

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with liposarcoma.

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

+16 more

Exclusion Criteria

I have had treatment for liposarcoma before.

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.

+9 more

Participant Groups

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.

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.