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Safety and Effectiveness Study of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With NSCLC

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ClinicalTrials.gov Identifier: NCT02037997
Recruitment Status : Unknown
Verified February 2016 by Chang Jian Hua, Fudan University.
Recruitment status was:  Recruiting
First Posted : January 16, 2014
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Chang Jian Hua, Fudan University

Study Description
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Brief Summary:
The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With EGFR - TKI Resistance of EGFR Mutations

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: docetaxel Drug: pemetrexed Drug: Erlotinib Phase 2

Detailed Description:
from the first cycle of treatment (day one) to two month after the last cycle
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemotherapy in Combination With Erlotinib, or Sequential Chemotherapy for Erlotinib for Treatment, EGFR - TKI Resistance of EGFR Mutations in Patients With NSCLC Randomized Controlled Phase II Clinical Study
Study Start Date : December 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: combination with Erlotinib
Erlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2
 Drug: docetaxel
docetaxel 75mg/m2 ivgtt D1

Drug: pemetrexed
pemetrexed 500mg/m2 ivgtt D1

Drug: Erlotinib
Erlotinib 150mg qd
Active Comparator: sequential chemotherapy for Erlotinib
docetaxel 75mg/m2 or pemetrexed 500mg/m2，after PD，Erlotinib 150mg qd
 Drug: docetaxel
docetaxel 75mg/m2 ivgtt D1

Drug: pemetrexed
pemetrexed 500mg/m2 ivgtt D1

Drug: Erlotinib
Erlotinib 150mg qd


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sign the informed consent
  2. ≥18 years
  3. According to RECIST 1.1 standard, at least one measurable lesions
  4. Histology and cytology confirmed with unfavorable surgical locally advanced stage (stage IIIB) or metastatic NSCLC (IV), Sensitive EGFR gene mutation
  5. Palliative treatment has received two medicine first-line platinum-based chemotherapy and EGFR - TKI second-line treatment and objective clinical benefit (CR, PR or SD is more than 6 months), RESIST standard curative effect evaluation for progress
  6. PS=0,1,2
  7. No serious blood, heart, lung, liver and kidney dysfunction, and immune deficiency
  8. Hb≥9g/dL；WBC≥3*109/L，ANC≥1.5*109/L，PLT≥75*109/L
  9. Men or women of childbearing age in the experiment are willing to take contraceptive measures
  10. Estimated survival period for 3 months or more

Exclusion Criteria:

  1. The palliative chemotherapy ever use docetaxel and pemetrexed
  2. small cell lung cancer non small cell hybrid
  3. Women during pregnancy or lactation
  4. In the past the anti-tumor treatment of any outstanding ease of > CTCAE 2 levels of toxicity
  5. Ccr<30 ml/min (calculated by Cockcroft-Gault formula)
  6. hepatic insufficiency： Tbil> 1.5×ULN ALT and AST > 2.5×ULN (Patients with liver metastasis>5×ULN) Alkaline phosphatase>2.5 ×ULN(Patients with liver metastasis>5×ULN)
  7. Severe symptomatic heart disease
  8. Symptomatic brain metastases
  9. In the last 5 years have been or are suffering from other histological types of malignant tumor
  10. There are serious or uncontrolled systemic diseases
  11. During the study period planned radiotherapy on target lesion
  12. During the study period, plans to use other antineoplastic therapy
  13. Clinical study on treatment of 30 days beginning period prior to participate in any study drug
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037997


Contacts
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Contact: Chang J hua, PD 13916619284 changjianhua@163.com

Locations
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China, Shanghai
Cancer hospital Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Chang J hua, PD    13916619284    changjianhua@163.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Chang J hua, PD Fudan University
More Information
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Responsible Party: Chang Jian Hua, attending, Fudan University
ClinicalTrials.gov Identifier: NCT02037997    
Other Study ID Numbers: CJH-Erlotinib-2013
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Keywords provided by Chang Jian Hua, Fudan University:
PFS
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
 Erlotinib Hydrochloride
Pemetrexed
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors