Nanoliposomal Irinotecan in Head & Neck and Esophagus After Prior Platinum-based Chemotherapy or Chemoradiotherapy

NCT03712397 | Completed Phase 2 DMC

• 1 other identifier: T2317
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 4

Brief Summary

This is an open-label, single arm, multicenter phase 2 study. The study is to evaluate the activity of a combination therapy with nal-IRI (PEP02, MM-398, Onivyde®) plus 5-FU and leucovorin in patients with squamous cell carcinoma of head \& neck and esophagus failed to platinum-based treatment in prior chemotherapy or chemoradiotherapy. The primary endpoint is to assess the objective tumor response rate (ORR). Eligible patients will be enrolled to receive combination therapy of nal-IRI plus 5-FU and Leucovorin on day 1, every 2 weeks. Every 2 weeks will be counted as one cycle. Treatment will continue until disease progression, unacceptable toxicity or other condition meeting the discontinuation criteria.

Conditions

Head & Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Objective tumor response rate

  Objective tumor response rate

  6 weeks

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

  2-year

• Treatment toxicities and safety profiles

  2-year

• UGT1A family - UGT1A1 and UGT1A9 with toxicity

  2-year

• cytokine and chemokine before and after treatment

  2-year

Study Arms (1)

nal-IRI in Head & Neck cancer

EXPERIMENTAL

nal-IRI 80 mg/m2 for 90 minutes in sequence at day 1, every 14 days counted as one cycle

Drug: nanoliposomal irinotecan

Interventions

nanoliposomal irinotecan DRUG

combination therapy of nal-IRI , leucovorin and 5-FU in sequence at day 1, every 14 days counted as one cycle

Also known as: nal-IRI

nal-IRI in Head & Neck cancer

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ages ≥ 20 years old
• Unresectable locally advanced, recurrent or metastatic diseases ineligible or unsuitable for further surgical or radiation interventions
• Documented disease progression within 6 months after treatment by prior platinum-based systemic chemotherapy or concurrent chemoradiotherapy. Patients who are intolerable to platinum-based systemic chemotherapy after at least 6 weeks' treatment interval or concurrent chemoradiotherapy after at least 3 weeks' treatment interval will be also eligible. Patients who have prior anti-EGFR and anti-PD1/anti-PDL1 treatment will be still eligible.
• ECOG Performance Status 0 and 1
• Documented measurable disease as defined by RECIST v1.1
• Adequate hematologic parameters, and hepatic and renal functions defined as :absolute neutrophil count ≥ 1,500/μL , platelets ≥ 100,000/μL ,total bilirubin: within normal range ,AST/ALT ≤ 2.5X ULN (≤ 5X ULN if attributable to liver metastases) ,serum creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 40 mL/min (by calculated or 24-hour urine collection)
• Normal ECG or ECG without any clinical significant findings
• Recovered from the effects of any prior surgery, radiotherapy, or other anti- neoplastic therapy

You may not qualify if:

• Received prior nal-IRI (PEP02, MM-398, Onivyde) or irinotecan therapy
• History of allergic reaction to liposome product, fluropyrimidines, or leucovorin
• Patient with liver cirrhosis with Child-Pugh score ≥ 8 (Late Child-Pugh B and Child-Pugh C)
• Active CNS metastasis defined by clinical symptoms, cerebral edema, steroid or anti-convulsant requirement, or progressive growth. Patients with a history of CNS metastasis or cord compression are allowed in the study if they have been treated and are clinically stable
• With clinically significant gastrointestinal disorder including bleeding, inflammation, occlusion or diarrhea \> grade 1
• With uncontrolled intercurrent illness that could limit study compliance or judged to be ineligible for the study by the investigators including, but not limited to, any of the following: ongoing or active infection requiring antibiotic treatment symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia psychiatric illness or social situation that would preclude study compliance
• Any major surgery, radiotherapy or anti-cancer therapy within 2 weeks. Patients receiving feeding stomy, esophageal stent and tracheal stent are still eligible to the study
• History of other primary malignancy within 5 years except curatively treated non-melanoma skin cancer or treated cervical carcinoma in situ, or stage 1 to stage 3 head and neck cancer which is disease-free for two or more years.
• Pregnant or breast feeding women (a urine pregnancy test must be performed on all patients who are of childbearing potential before entering the study, and the result must be negative)

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• China Medical University Hospital: collaborator
• Tri-Service General Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator
• National Cheng-Kung University Hospital: collaborator

Study Sites (4)

China Medical University Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Yang MH, Wu SY, Ho IW, Chiang NJ, Hsaio CF, Lin CY, Lien MY, Chang PM, Chen JH, Hsieh CY, Hong RL, Lee CT, Chen LT, Liu TW, Chiu CF, Bai LY. Nanoliposomal Irinotecan in Combination With 5-Fluorouracil and Leucovorin for Advanced Head and Neck and Esophageal Squamous Cell Carcinoma After Prior Platinum-Based Chemotherapy or Chemoradiotherapy: A Multicenter Phase II Trial. Cancer Med. 2025 Oct;14(20):e71307. doi: 10.1002/cam4.71307.

  PMID: 41117518 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

irinotecan sucrosofate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Li-Yuan Bai, PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 19, 2018
• Study Start: December 24, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4)