Naloxegol in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:October 13, 2017
End Date:August 2027
Contact:Pankaj Gupta, MD
Email:pankaj.gupta@va.gov
Phone:612-467-4135

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A Randomized, Double-Blind, Placebo-Controlled Pilot Study of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-Small Cell Lung Cancer

This randomized pilot clinical trial studies the side effects and best dose of naloxegol and
to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer.
Naloxegol may relieve some of the side effects of opioid pain medication and fight off future
growth in the cancer.

PRIMARY OBJECTIVES:

I. To determine feasibility and safety of long-term administration of two doses of a
peripheral opioid receptor antagonist in patients with advanced non-small cell lung cancer
(NSCLC) receiving first-line systemic therapy.

SECONDARY OBJECTIVES:

I. To explore whether patients randomized to one or both of the two study drug arms have less
decline in health-related quality of life (HRQoL) than patients randomized to placebo.

II. To estimate the difference in the pain levels and opioid/non-opioid analgesic
requirements between patients receiving naloxegol or placebo.

III. To estimate the difference in the adverse peripheral effects of opioids (e.g.
constipation, nausea/emesis, dry mouth and urinary retention) between patients receiving
naloxegol or placebo.

IV. To explore whether there is a signal that naloxegol may be associated with longer
progression-free survival (PFS) and overall survival (OS).

V. To evaluate the difference in discontinuation rate of systemic therapy due to adverse
events (AEs) and deaths attributable to systemic therapy.

After completion of study treatment, patients are followed up every 3 months.

Inclusion Criteria:

- Advanced (stage IIIB or IV) non-small cell lung cancer diagnosed by biopsy of the
primary or metastatic site (American Joint Committee on Cancer 7.0)

- No known presence of known EGFR or EML4-ALK driver mutations in the tumor

- Initiation of first-line chemotherapy with a platinum-pemetrexed-based regimen within
14 days of registration or planning to initiate within 14 days after registration; no
planned initiation of definitive (potentially curative) concurrent chemo-radiation

- No prior systemic therapy for advanced NSCLC, including chemotherapy, targeted therapy
or immunotherapy; prior palliative radiation permitted; prior adjuvant
chemotherapy/radiation is permitted

- No past or current use of mixed opioid agonist/opioid antagonists or other opioid
antagonists

- No methadone within 4 weeks prior to registration

- Patients must have used opioid medication(s) for pain at some time in the 4 weeks
prior to registration; current use of opioids (at the time of registration) and/or
later during the course of the study is permitted but not required

- Expected survival > 3 months

- No concurrently active second invasive malignancies except non-melanoma skin cancer

- No history of gastrointestinal obstruction, or conditions that increase the risk of
gastrointestinal obstruction, perforation, bleeding or impairment of the
gastrointestinal wall; no abdominal surgery within 60 days of registration

- No acute gastrointestinal conditions, such as: obstruction, fecal impaction,
obstipation, acute surgical abdomen, ongoing need for manual maneuvers to induce bowel
movements (such as digital evacuation)

- No conditions that may compromise blood-brain barrier permeability (e.g., multiple
sclerosis, recent brain trauma, Alzheimer's disease, or uncontrolled seizures)

- No symptomatic and untreated brain metastases; patients will be eligible for
study if radiation therapy for brain metastases was completed at least 7 days
prior to registration

- Patients having received stereotactic radiation will be eligible if the radiation
was completed at least 7 days prior to registration

- Patients having undergone surgical resection of brain metastases will be eligible
after they have healed and recovered from the surgical intervention sufficiently
to start systemic treatment for NSCLC, as determined by a neurosurgeon

- No known leptomeningeal carcinomatosis

- No history of myocardial infarction =< 6 months prior to registration; no current
symptomatic congestive heart failure, uncontrolled angina, or uncontrolled cardiac
arrhythmias

- No severe hepatic impairment (Child-Pugh class C) or acute liver disease

- No known serious or severe hypersensitivity reaction to naloxegol or any of its
excipients

- No concurrent use of moderate/strong CYP3A4 inhibitors, or strong CYP3A4 inducers

- Not pregnant and not nursing; for women of childbearing potential only, a negative
pregnancy test done =< 7 days prior to registration is required; a female of
childbearing potential is a sexually mature female who: 1) has not undergone a
hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal
for at least 12 consecutive months (i.e., has had menses at any time in the preceding
12 consecutive months)

- Age ≥ 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Absolute neutrophil count (ANC) >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Calculated (calc.) creatinine clearance >= 60 mL/min calculated using the
Cockcroft-Gault formula

- Total bilirubin =< 1.2 x upper limit of normal (ULN) unless due to Gilbert's disease

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper
limit of normal (ULN)
We found this trial at
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3501 Cranberry Blvd
Weston, Wisconsin 54476
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Marshfield Clinic - Weston Center The Clinic was incorporated under Wisconsin law in 1916 and...
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
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Phone: 800-767-9355
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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2500 N State St
Jackson, Mississippi 39216
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524 South Park Street
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(269) 341-7654
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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1800 West Charleston Boulevard
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University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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4805 Northeast Glisan Street
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Seattle, Washington 98104
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'Aiea, Hawaii 96701
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98-1079 Moanalua Road
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2226 Liliha Street
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'Aiea, Hawaii 96701
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
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Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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2000 Ogden Ave
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3325 Pocahontas Road
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265 Fremont St
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800 Farson Street
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1233 North 30th Street
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300 N. Seventh St.
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1505 Eastland Drive
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100 E Idaho St
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Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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1100 Balsam Ave
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915 Highland Blvd
Bozeman, Montana 59715
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7575 Grand River Avenue
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
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3123 Medical Dr
Caldwell, Idaho 83605
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
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1600 South Canton Center Road
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211 Saint Francis Drive
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
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Chattanooga, Tennessee 37404
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14650 East Old US Highway 12
Chelsea, Michigan 48118
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775 South Main Street
Chelsea, Michigan 48118
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1200 West Harrison Stree
Chicago, Illinois 60607
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272 Hospital Rd
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Cincinnati, Ohio 45236
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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Cincinnati, Ohio 45242
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Cincinnati, OH
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Cincinnati, Ohio 45247
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Cincinnati, OH
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Cincinnati, Ohio 45255
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Cincinnati, OH
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Clackamas, Oregon 97015
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
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Clackamas, OR
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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Clackamas, OR
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