Evaluation of the High Dose of Icotinib in Advanced Lung Cancer Patients After Failure of Target Therapy

An Open, Single Center Trial to Evaluate the Efficacy and Safety of Dose Escalation of Icotinib in Advanced NSCLC Patients After TKI Therapy

The purpose of this study is to evaluate the efficacy and safety of dose escalation of Icotinib in advanced non small cell lung cancer (NSCLC) patients after the therapy of Icotinib, Iressa and Tarceva.

Study Overview

• Status: Unknown
• Conditions: NSCLC
• Intervention / Treatment: Drug: Icotinib

Detailed Description

• 1:to evaluate the efficacy correlation between the tyrosine kinase inhibitor (TKI) drugs and high-dose Icotonib group in advanced NSCLC patients with high -dose Icotinib going on after the routine TKI therapy
• 2 to evaluate the efficacy correlation between different high-dose group in advanced NSCLC patients with high -dose Icotinib going on after the routine TKI therapy

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hu Liu, MD; Phone Number: 865512922987; Email: drliuhu@gmail.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230032
      • Recruiting
      • Dept. of Oncology,The First Affiliated Hospital of Anhui Medical Univesrsity
      • Principal Investigator: Yueyin Pan, MD
      • Contact: Hu Liu, MD; Phone Number: 865512922987; Email: drliuhu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. NSCLC patients were confirmed by histology or cytology
2. The time interval must be over 4 weeks from previous chemotherapy to registration to participate in this experiment if he or she received chemotherapy,and also have any toxicity to recover.

3. at least one measureable lesion accord to RECIST 1.1 criteria and the lesion accepted no radiotherapy.

   • 1 at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology.
   • 2 a single diameter of lesion could be measured by at least one of the following methods: Chest or abdominal computed tomography(CT)or magnetic resonance imaging(MRI),conventional methods of diameter at least 20mm diameter spiral CT OR at least 10mm.
4. ECOG 0-2 score
5. at least 12 weeks of expected survival time
6. Women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures
7. understand and sign a written informed consent voluntarily.

Exclusion Criteria:

If the subject meet any of the following exclusion criteria ,he is no eligible to participate in this study,

1. Before enrollment in this trial have used Erbitux, Herceptin and carried out anti-cancer therapy.
2. use of phenytoin, carbamazepine, rifampicin, phenobarbital or St. John's Wort when take this trial
3. severe allergies to Icotinib

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Icotinib; Patients can accept the treatment with Icotinib (250/375/500mg tid) until disease progression or unacceptable toxicity occurred. The overall study period takes about 24 months	Drug: Icotinib; Patients can accept the treatment with Icotinib (250/375/500mg tid) until disease progression or unacceptable toxicities occurred. The overall study period takes about 24 months; Other Names: high dose of Icotinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety and efficacy	The efficacy of dose escalation of Icotinib in advanced NSCLC patients after failure of TKI (Icotinib 125mg po tid. Iressa 250mg po qd. Tarceva 150mg po qd) therapy will be evaluated according to the revised RECIST 1.1 (Response Evaluation Criteria In Solid Tumors).; The safety of high dosage of Icotinib will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.	2 years

Collaborators and Investigators

• Sponsor: Anhui Medical University
• Investigators: Principal Investigator: Yueyin Pan, MD, Anhui Medical University

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 4, 2012
• First Submitted That Met QC Criteria: October 15, 2013
• First Posted (Estimate): October 16, 2013

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Self Efficacy; Adverse Reaction to Drug
• Other Study ID Numbers: DEI-ADNSCLC