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

NCT01965275 | Unknown Phase 2 DMC

• 1 other identifier: HDP-ADNSCLC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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）

Conditions

Self Efficacy; Drug Toxicity

Keywords

Advanced non-small cell lung cancer; High-dose; Pulsatile; EGFR-TKIs

Outcome Measures

Primary Outcomes (1)

• 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: 1. At least one target lesion that has not previously been radiated and is measurable according to RECIST v1.1; 2. 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

  1 year

Study Arms (1)

Erlotinib or Gefitinib

EXPERIMENTAL

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

Drug: Erlotinib or Gefitinib

Interventions

Erlotinib or Gefitinib 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

Also known as: high-dose, pulsatile Erlotinib or Gefitinib

Erlotinib or Gefitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

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

Hefei, Anhui, 230032, China

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Erlotinib Hydrochloride; Gefitinib

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yueyin Pan, PHD,MD

  Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanzhe Zhu, MD

CONTACT

8655162922987; yanzhe918@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 18, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

CN (1)