Clinical trial NCT01131429: A Chinese Randomized Crossover Study of Erlotinib Versus Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neoplasms, Lung
Carcinoma, Non-Small Cell Lung
Drug Therapy
Genes, EGFR
Keywords: mutation analysis
first-line
second-line
targeted therapy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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 .


Eligibility 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.

Primary outcomes:
measure: Overall survival
timeFrame: three year
Secondary outcomes:
measure: progression-free survival during the first-line treatment
timeFrame: 1 year
measure: progression-free time during the second-line treatment
timeFrame: 2 years
measure: quality of life during the first-line therapy
timeFrame: every 3 weeks during first-line therapy
measure: quality of life during the second-line therapy
timeFrame: every 3 weeks during the second-line therapy
measure: response rates during the first-line treatment
timeFrame: at 6 months from treatment initiation
measure: response rates during the second-line treatment
timeFrame: every 3 weeks during the treament, and and every 6 weeks thereafter
measure: toxicity during the first-line treatment
timeFrame: at 12 months from treatment initiation
measure: toxicity during the second-line treatment
timeFrame: end of study
measure: preditive and prognostic markers for chemotherapy or erlotinib
timeFrame: end of study
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital, Beijing, China
name: Liang-An Chen, M.D., Ph.D.
role: STUDY_CHAIR
References: