Eribulin + Radiation for Abdominal Cancer

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: OHSU Knight Cancer Institute

Must not be taking: Eribulin, TdP risk drugs

Disqualifiers: Distant metastases, Uncontrolled arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose and assess the side effects of the chemotherapy drug eribulin mesylate when combined with radiation therapy. The focus is on treating retroperitoneal liposarcoma, a type of abdominal cancer that can be surgically removed. The study combines eribulin mesylate, which inhibits cancer cell growth, with high-energy x-rays from radiation to target the tumor. Individuals with liposarcoma suitable for surgery and radiation may be ideal candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking cancer research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require you to stop using herbal supplements unless approved by a study pharmacist. You can continue using marijuana or its derivatives.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that eribulin mesylate, a chemotherapy drug, has been studied for its safety. Common side effects include tiredness and low blood cell counts, affecting over 25% of patients in some cases. Many patients also experience stomach issues and general weakness, with more than half reporting these problems in some studies.

Research suggests that intensity-modulated radiation therapy (IMRT) is generally well-tolerated. IMRT can reduce the risk of damaging nearby healthy tissues, especially in the abdomen and pelvis, resulting in fewer side effects like stomach and urinary problems compared to older radiation methods.

Overall, while both treatments have side effects, past studies indicate they are known and manageable. Participants should discuss potential risks and benefits with their doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Eribulin Mesylate is unique because it targets cancer cells by interfering with their ability to divide, which is different from many standard treatments that often focus on other aspects of cancer cell survival. Researchers are excited about combining it with Intensity-Modulated Radiation Therapy (IMRT) because IMRT allows for precise targeting of tumors with radiation, minimizing damage to surrounding healthy tissue. This combination has the potential to enhance treatment effectiveness and reduce side effects, making it a promising option for patients with abdominal cancer.

What evidence suggests that eribulin mesylate combined with radiation therapy might be an effective treatment for retroperitoneal liposarcoma?

Research has shown that eribulin mesylate offers promising results for treating advanced liposarcoma, a type of cancer. One study found that patients receiving eribulin mesylate lived longer than those receiving other treatments, suggesting it might help stop tumors from growing and spreading. In this trial, participants will receive eribulin mesylate combined with intensity-modulated radiation therapy (IMRT).

IMRT precisely targets tumors, protecting nearby healthy tissues. Studies have found that IMRT can help patients live longer and control tumor growth. Using eribulin mesylate and IMRT together in this trial might effectively target and shrink tumors in abdominal cancer. ^{1 3 4 6 7}

Who Is on the Research Team?

Lara Davis, MD

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive eribulin mesylate IV and undergo intensity-modulated radiation therapy. Treatment repeats every 21 days for up to 3 cycles.

9 weeks

Multiple visits for IV administration and daily radiation therapy

Surgery

Participants may undergo surgery within 3-10 weeks after radiation therapy.

3-10 weeks post-radiation

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-ups at 2 weeks, 9 weeks, and then every 6 months for 10 years.

10 years

Follow-up visits at specified intervals

What Are the Treatments Tested in This Trial?

Interventions

• Eribulin Mesylate
• Intensity-Modulated Radiation Therapy

Trial Overview

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.

How Is the Trial Designed?

Group I: Treatment (eribulin mesylate, IMRT, surgery) Experimental Treatment 6 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.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

In a phase II study involving 66 patients with advanced non-small cell lung cancer (NSCLC) previously treated with taxanes, eribulin mesylate showed a modest objective response rate of 5%, with a median duration of response lasting 7.8 months, particularly in taxane-sensitive patients.

Eribulin was well tolerated, with primarily hematologic toxicities and only two cases of grade 3 neuropathy, indicating it may be a safe treatment option for patients with pretreated NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of halichondrin B analog eribulin mesylate (E7389) in patients with advanced non-small cell lung cancer previously treated with a taxane: a California cancer consortium trial. Gitlitz, BJ., Tsao-Wei, DD., Groshen, S., et al.[2022]

In a study of 20 patients with intermediate-risk prostate cancer receiving hypofractionated radiotherapy (HRT), no acute gastrointestinal (GI) toxicity was observed, highlighting the safety of this treatment approach.

Only one patient (5%) experienced late GI toxicity (grade 3 rectal bleeding) within the first year after treatment, indicating that HRT has minimal long-term effects on rectal mucosa, further supporting its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and Late Rectal Toxicity Following Hypofractionated Radiotherapy in Patients With Prostate Cancer: Results of a Prospective Study. Kounadis, G., Syrigos, N., Kougioumtzopoulou, A., et al.[2022]

Eribulin mesylate (ERI) demonstrated statistically longer overall survival compared to treatment by physician's choice and a combination of gemcitabine and vinorelbine in patients with metastatic breast cancer, based on a network meta-analysis of seven trials.

In patients with triple negative breast cancer, ERI also showed a significant overall survival benefit compared to capecitabine, highlighting its potential as an effective treatment option in this specific subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Network meta-analysis of eribulin versus other chemotherapies used as second- or later-line treatment in locally advanced or metastatic breast cancer. Zhao, Q., Hughes, R., Neupane, B., et al.[2021]

Intensity-modulated radiation therapy (IMRT) offers improved dose targeting, which may reduce normal tissue damage compared to traditional radiation methods, making it a promising option in radiation oncology.

While preliminary results for IMRT in treating head and neck and prostate cancers are encouraging, the clinical data is still developing, and the number of patients studied remains relatively small.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy: emerging cancer treatment technology. Hong, TS., Ritter, MA., Tomé, WA., et al.[2018]

In a study comparing the effects of eribulin mesylate and paclitaxel on mice with preexisting paclitaxel-induced peripheral neuropathy (PN), eribulin mesylate did not worsen nerve function, while additional paclitaxel treatment significantly decreased nerve conduction velocity and amplitude.

These findings suggest that eribulin mesylate may be a safer alternative for patients with advanced breast cancer who have experienced PN from previous paclitaxel treatment, potentially allowing for continued chemotherapy without exacerbating nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropathy-inducing effects of eribulin mesylate versus paclitaxel in mice with preexisting neuropathy. Wozniak, KM., Wu, Y., Farah, MH., et al.[2021]

In a study of 59 patients with extremity soft tissue sarcomas, intensity-modulated radiotherapy (IMRT) resulted in late toxicities in 75% of patients, with the majority being mild to moderate (G1-2), including functional limitations and chronic pain.

A larger volume of healthy soft tissue surrounding the treatment area (greater than 3500 cm³) was associated with reduced late toxicities, suggesting that careful planning of radiotherapy can help minimize side effects for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of intensity-modulated radiotherapy toxicity in extremity soft tissue sarcomas patients: A role for irradiated healthy soft tissue volume? Bourdais, R., Achkar, S., Honoré, C., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10102841/

Results from the Advanced Gastric Cancer Expansion Cohort

E7389-LF 2.0 mg/m2 every 3 weeks was tolerable and showed preliminary activity for the treatment of patients with gastric cancer. Translational ...

2.

halaven.com

halaven.com/hcp/advanced-liposarcoma/efficacy

Phase III Trial Results & Efficacy

Learn about the Phase III trial results for the safety & efficacy for HALAVEN® (eribulin mesylate) Injection for Advanced Liposarcoma.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0959804922001447

Phase 1 study of the liposomal formulation of eribulin ...

Objective response rate was 35.7% (95% confidence interval [CI]: 18.6–55.9) for all patients and 42.9% (95% CI: 21.8–66.0) for patients with HR+ BC. Median ...

4.

jgo.amegroups.org

jgo.amegroups.org/article/view/91926/html

Liposomal eribulin (E7389-LF) plus nivolumab: a potential ...

The results presented by Kawazoe et al. present a promising signal of efficacy of E7389-LF plus nivolumab in patients with advanced gastric ...

5.

aetna.com

aetna.com/cpb/medical/data/800_899/0831.html

Eribulin Mesylate (Halaven) - Medical Clinical Policy ...

Median PFS (2.2 vs 2.6 months, HR = 1.07 [95% CI 0.84-1.38]; P = 0.58) and ORR (5% vs 7%) were similar between eribulin- and dacarbazine-treated patients. Grade ...

6.

halaven.com

halaven.com/hcp/metastatic-breast-cancer/safety-profile

Safety profile demonstrated in the Phase III EMBRACE trial

In patients with liposarcoma and leiomyosarcoma receiving HALAVEN, the most common adverse reactions (≥25%) reported in patients receiving HALAVEN were fatigue ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6192912/

Safety Results and Analysis of Eribulin Efficacy according ...

The most frequently observed toxicities were cytopenias (59.6% of included patients), gastro-intestinal disorders (59.2%), and asthenia (56.4%). The most ...