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

Conditions

• Head & Neck Cancer

Eligibility Criteria

Sex

ALL

Age

20 Years - N/A

Healthy Volunteers

Not accepted

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

Study Details

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.

Key Dates

Start date

Dec 24, 2018

Status verified

Apr 2023

Primary completion

Dec 31, 2022

Completion

Dec 31, 2022

Study Design

Enrollment

59 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: nal-IRI in Head & Neck cancer
  nal-IRI 80 mg/m2 for 90 minutes in sequence at day 1, every 14 days counted as one cycle

Primary Outcome Measure

Objective tumor response rate [ Time Frame: 6 weeks ]