Clinical trial NCT01963195: Evaluation of the High Dose of Icotinib in Advanced Lung Cancer Patients After Failure of Target Therapy
Official title: An Open, Single Center Trial to Evaluate the Efficacy and Safety of Dose Escalation of Icotinib in Advanced NSCLC Patients After TKI Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: NSCLC
Keywords: Adverse Reaction to Drug
Self Efficacy
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: safety and efficacy
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Dept. of Oncology,The First Affiliated Hospital of Anhui Medical Univesrsity
state: Anhui
Study officials:
affiliation: Anhui Medical University
name: Yueyin Pan, MD
role: PRINCIPAL_INVESTIGATOR
References: