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Alliance A221504

Status:

Open | Phase II

Official Title:

A Randomized, Double-Blind, Placebo-Controlled Pilot Study Of An Oral, Selective Peripheral Opioid Receptor Antagonist In Advanced Non-Small Cell Lung Cancer (Adenocarcinoma)

Study Purpose:

To determine feasibility and safety of long-term administration of two doses of a peripheral opioid receptor antagonist in patients with advanced NSCLC receiving first-line pemetrexed-based chemotherapy.

Interventions:

  • Study agents: Naloxegol; or placebo
  • Quality of Life questionnaires including bowel function and pain medication diary.
  • ARM 1: Naloxegol 12.5 mg orally once daily
  • ARM 2: Naloxegol 25 mg orally once daily
  • ARM 3:  Placebo orally once daily.
  • Drug may continue for up to 2 years
  • Clinic visits at 3 and 6 weeks, then every 6 weeks for 1 year.

 Patients are followed every 3 months for 2 years.

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

Diagnosis:

Advanced (stage IIIB or IV) lung adenocarcinoma diagnosed by biopsy of the primary or metastatic site.

Eligibility:

Must have used opioid medications for pain at some time in the 4 weeks prior to registration.

ECOG PS 0-2.

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

Planned use of first –line chemotherapy with a platinum-based pemetrexed regimen.

No prior systemic treatment including targeted therapy or immunotherapy.

Prior palliative radiation is allowed prior to start of treatment.

No prior or current use of mixed opioid agonist/opioid antagonists or other opioid antagonists.

No methadone within 4 weeks prior to registration.

No history of gastrointestinal obstruction or conditions that increase the risk of obstruction, perforation, bleeding, or impairment of the gastrointestinal tract.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

A221504

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!