A Chinese Randomized Crossover Study of Erlotinib Versus Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2010 by Chinese PLA General Hospital
Sponsor:
Information provided by:
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01131429
First received: May 25, 2010
Last updated: May 26, 2010
Last verified: April 2010
  Purpose

Objective: the objective of this study in china is to clarify, whether the overall survival is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those receiving first-line docetaxel/cisplatin plus second-line erlotinib .


Condition Intervention Phase
Neoplasms, Lung
Carcinoma, Non-Small Cell Lung
Drug Therapy
Genes, EGFR
Drug: Erlotinib
Drug: Docetaxel
Drug: Cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Survival Analysis of A Chinese Randomized Crossover Study Comparing Erlotinib to Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • Overall survival [ Time Frame: three year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression-free survival during the first-line treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • progression-free time during the second-line treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • quality of life during the first-line therapy [ Time Frame: every 3 weeks during first-line therapy ] [ Designated as safety issue: No ]
  • quality of life during the second-line therapy [ Time Frame: every 3 weeks during the second-line therapy ] [ Designated as safety issue: No ]
  • response rates during the first-line treatment [ Time Frame: at 6 months from treatment initiation ] [ Designated as safety issue: No ]
  • response rates during the second-line treatment [ Time Frame: every 3 weeks during the treament, and and every 6 weeks thereafter ] [ Designated as safety issue: Yes ]
  • toxicity during the first-line treatment [ Time Frame: at 12 months from treatment initiation ] [ Designated as safety issue: Yes ]
  • toxicity during the second-line treatment [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
  • preditive and prognostic markers for chemotherapy or erlotinib [ Time Frame: end of study ] [ Designated as safety issue: No ]
    tissues for markers analysis are acquired during diagnosis procedure with informed consent.


Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: first-line erlotinib
erlotinib in first-line treatment and docetaxel/cisplatin in second-line treatment
Drug: Erlotinib
Erlotinib 150 mg/d per os until proven disease progression
Drug: Docetaxel
Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment
Drug: Cisplatin
cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment
Active Comparator: second-line erlotinib
docetaxel/cisplatin in first-line treatment and erlotinib in second-line treatment
Drug: Docetaxel
Docetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
Drug: Cisplatin
Cisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
Drug: Erlotinib
Erlotinib 150 mg/d per os as second-line treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients aged over 18 years
  • Histologically proven lung adenocarcinoma
  • clinical stage IIIB/IV
  • ECOG performance status 0-2
  • Had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma
  • At least one measurable lesion (according to RECIST)
  • Provision of written informed consent
  • Life expectancy of at least 12 weeks

Exclusion Criteria:

  • History of malignant disease.
  • Evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
  • Expected life expectancy less than 2 months
  • As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  • Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases)
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
  • Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131429

Contacts
Contact: Liang-An Chen, MD, phD 86-10-66939361 chenla301@263.net

Locations
China, Beijing
Chinese PLA General Hospital Not yet recruiting
Beijing, Beijing, China, 100853
Contact: Liang-An Chen, MD, phD    86-10-66939361    chenla301@263.net   
Principal Investigator: Liang-An Chen, MD, phD         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Chair: Liang-An Chen, M.D., Ph.D. Chinese PLA General Hospital, Beijing, China
  More Information

No publications provided

Responsible Party: Liang-An Chen, M.D., Ph.D, Chinese PLA General Hospital, Beijing, China
ClinicalTrials.gov Identifier: NCT01131429     History of Changes
Other Study ID Numbers: PLAGH-TKIs
Study First Received: May 25, 2010
Last Updated: May 26, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese PLA General Hospital:
mutation analysis
first-line
second-line
targeted therapy

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Cisplatin
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014