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

Primary Purpose

Self Efficacy, Drug Toxicity

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Erlotinib or Gefitinib
Sponsored by
Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self Efficacy focused on measuring Advanced non-small cell lung cancer, High-dose, Pulsatile, EGFR-TKIs

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

    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.

Sites / Locations

  • Dept. of Oncology,The First Affiliated Hospital of Anhui Medical UnivesrsityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erlotinib or Gefitinib

Arm Description

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

Outcomes

Primary Outcome Measures

efficacy and safety
To evaluate the efficacy and safety by treating the advanced NSCLC patients who have failure of standard dose EGFR-TKIs with high-dose, pulsatile Erlotinib(600mg every 4 days) or Gefitinib (1000mg every 4 days) Radiologically measurable disease by RECIST v1.1 criteria: At least one target lesion that has not previously been radiated and is measurable according to RECIST v1.1; Acceptable radiologic procedures for disease assessment include contrast enhanced conventional or spiral computed tomography (CT), or contrast enhanced magnetic resonance imaging (MRI); Non-contrast CT scan is acceptable only for subjects who are both allergic to intravenous contrast and unable to cooperate with MRI, or MRI is not available. The following are not allowed as sole documentation of target lesions: CT component of a positron emission tomography (PET)/CT,ultrasound alone, nuclear scans (including bone or PET scans), chest X-ray or bone radiographs, and tumor markers

Secondary Outcome Measures

Full Information

First Posted
October 10, 2013
Last Updated
May 3, 2017
Sponsor
Anhui Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01965275
Brief Title
High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced NSCLC Patients After Failure of Standard Dose EGFR-TKIs
Official Title
An Open,Multi Center Trial to Evaluate the Efficacy and Safety of High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced Non-Small Cell Lung Cancer Patients After Failure of Standard Dose EGFR-TKIs
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anhui Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self Efficacy, Drug Toxicity
Keywords
Advanced non-small cell lung cancer, High-dose, Pulsatile, EGFR-TKIs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erlotinib or Gefitinib
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Erlotinib or Gefitinib
Other Intervention Name(s)
high-dose, pulsatile Erlotinib or Gefitinib
Intervention Description
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
Primary Outcome Measure Information:
Title
efficacy and safety
Description
To evaluate the efficacy and safety by treating the advanced NSCLC patients who have failure of standard dose EGFR-TKIs with high-dose, pulsatile Erlotinib(600mg every 4 days) or Gefitinib (1000mg every 4 days) Radiologically measurable disease by RECIST v1.1 criteria: At least one target lesion that has not previously been radiated and is measurable according to RECIST v1.1; Acceptable radiologic procedures for disease assessment include contrast enhanced conventional or spiral computed tomography (CT), or contrast enhanced magnetic resonance imaging (MRI); Non-contrast CT scan is acceptable only for subjects who are both allergic to intravenous contrast and unable to cooperate with MRI, or MRI is not available. The following are not allowed as sole documentation of target lesions: CT component of a positron emission tomography (PET)/CT,ultrasound alone, nuclear scans (including bone or PET scans), chest X-ray or bone radiographs, and tumor markers
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: If the subject meet any of the following exclusion criteria ,he/she is no eligible to participate in this study Have chronic toxicity reaction(above grade 2) and not recovered( hair loss not include) Have Appeared skin rashes or diarrhea(above grade 3),or have any reason lead to decrement during standard dose EGFR-TKIs treatment Female subjects who are in pregnancy or lactation，or of childbearing age but don't take any contraceptive measures Current enrollment in another therapeutic clinical study Have any symptoms of brain metastases or leptomeningeal metastases Subjects will not be eligible if they have history of prior malignancy in past 5 years 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanzhe Zhu, MD
Phone
8655162922987
Email
yanzhe918@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yueyin Pan, PHD,MD
Organizational Affiliation
Anhui Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Oncology,The First Affiliated Hospital of Anhui Medical Univesrsity
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanzhe Zhu, MD
Phone
8655162922987
Email
yanzhe918@163.com
First Name & Middle Initial & Last Name & Degree
Yueyin Pan, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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