High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced NSCLC Patients After Failure of Standard Dose EGFR-TKIs

NCT ID: NCT01965275

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-12-31

Brief Summary

the purpose of this study is to evaluate the efficacy and safety of high-dose，pulsatile Erlotinib/Gefitinib in advanced non small cell lung cancer (NSCLC) patients after failure of standard dose EGFR-TKIs（Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors）

Detailed Description

To evaluate the efficacy and safety by treating the advanced non small cell lung cancer (NSCLC) patients who have failure of standard dose EGFR-TKIs(Erlotinib or Gefitinib ) with high-dose, pulsatile Erlotinib(450mg every 3 days) or Gefitinib (1000mg every 4 days)

Conditions

Self Efficacy; Drug Toxicity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erlotinib or Gefitinib

Patients received the treatment with high-dose, pulsatile Erlotinib(600 mg every 4 days) or Gefitinib (1000 mg every 4 days) until disease progression or unacceptable toxicity occurred. The overall study period takes about 12 months

Group Type: EXPERIMENTAL

Erlotinib or Gefitinib

Intervention Type: DRUG

Patients received the treatment with high-dose, pulsatile Erlotinib(600 mg every 4 days) or Gefitinib (1000 mg every 4 days) until disease progression or unacceptable toxicity occurred. The overall study period takes about 12 months

Interventions

Erlotinib or Gefitinib

Patients received the treatment with high-dose, pulsatile Erlotinib(600 mg every 4 days) or Gefitinib (1000 mg every 4 days) until disease progression or unacceptable toxicity occurred. The overall study period takes about 12 months

Intervention Type: DRUG

Other Intervention Names

high-dose, pulsatile Erlotinib or Gefitinib

Eligibility Criteria

Inclusion Criteria

• 1. NSCLC patients were confirmed by histology or cytology 2. Patients were ever treated with standard dose EGFR-TKIs(Erlotinib or Gefitinib )on which he/she achieved complete remission/partial remission,or maintained stable disease for 4 months.Disease progression at present (accord to RECISTv1.1 criteria） 3.At least one target lesion that has not previously been radiated and is measurable according to RECIST v1.1; 4.Have an ECOG PS of 0-2 5.At least 8 weeks of expected survival time 6.Have no serious cardiovascular,hepatobiliary or renal disorders 7.Provision of a voluntarily given, personally signed and dated, written informed consent document 8.Must be in accordance with the following laboratory biochemical data: Hgb≥80g/L，WBC≥3.0×10^9/L，ANC≥1.0×10^9/L， PLT≥80×10^9/L Renal function：SCr≤ULN Liver function： if no hepatic metastases:AST/ALT≤2.5ULN if hepatic metastases:AST/ALT≤5ULN

Exclusion Criteria

1. Have chronic toxicity reaction(above grade 2) and not recovered( hair loss not include)

2. Have Appeared skin rashes or diarrhea(above grade 3),or have any reason lead to decrement during standard dose EGFR-TKIs treatment

3. Female subjects who are in pregnancy or lactation，or of childbearing age but don't take any contraceptive measures

4. Current enrollment in another therapeutic clinical study

5. Have any symptoms of brain metastases or leptomeningeal metastases

6. Subjects will not be eligible if they have history of prior malignancy in past 5 years

7. Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this study or known drug abuse/alcohol abuse.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Pan Yueyin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yueyin Pan, PHD,MD

Role: PRINCIPAL_INVESTIGATOR

Anhui Medical University

Locations

Dept. of Oncology,The First Affiliated Hospital of Anhui Medical Univesrsity

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanzhe Zhu, MD

Role: CONTACT

yanzhe918@163.com

8655162922987

Facility Contacts

Yanzhe Zhu, MD

Role: primary

yanzhe918@163.com

8655162922987

Other Identifiers

HDP-ADNSCLC

Identifier Type: -

Identifier Source: org_study_id