Eribulin Mesylate and Radiation Therapy in Treating Patients With Retroperitoneal Liposarcoma That Can Be Removed by Surgery



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:12 - Any
Updated:6/27/2018
Start Date:March 19, 2018
End Date:February 28, 2022

Use our guide to learn which trials are right for you!

A Phase 1B Trial of Preoperative Eribulin and Radiation for Retroperitoneal Liposarcoma

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.

PRIMARY OBJECTIVES:

I. To determine the recommended phase 2 dose (RP2D) of radiation and eribulin mesylate
(eribulin) when used in combination for the preoperative treatment of retroperitoneal
liposarcoma.

SECONDARY OBJECTIVES:

I. To assess the feasibility of a preoperative chemoradiation protocol for retroperitoneal
liposarcoma.

II. to assess the surgical outcomes of retroperitoneal liposarcoma resections after
preoperative chemoradiation.

III. To assess preliminary anti-tumor activity of eribulin in combination with radiation in
subjects with retroperitoneal liposarcoma.

OUTLINE: This is a dose-escalation study of eribulin mesylate.

Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1 and 8 and
undergo intensity-modulated radiation therapy once daily (QD) 5 days a week beginning on day
8 of course 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease
progression or unacceptable toxicity. Patients may undergo surgery within 3-10 weeks after
radiation therapy.

After completion of study treatment, patients will be followed up at 2 weeks, 9 weeks, and
then every 6 months for 10 years.

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 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

- Female 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

- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

- Men and women 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 congenital long QT syndrome or torsades de pointes

- 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) women; NOTE: Pregnant women are excluded from this
study; breastfeeding should be discontinued

- Unable or unwilling to stop the use of herbal supplements; the use of marijuana or its
derivatives is allowed; the use of nutritional supplements may be allowed after review
by a study pharmacist to confirm no significant risk of interaction with eribulin or
radiation
We found this trial at
1
site
3181 S.W. Sam Jackson Park Road
Portland, Oregon 97239
503 494-7999
Principal Investigator: Lara E. Davis
Phone: 503-494-8423
OHSU Knight Cancer Institute OHSU Knight Cancer Institute is known worldwide for our contributions to...
?
mi
from
Portland, OR
Click here to add this to my saved trials