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

Carcinoma, Non-Small Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01131429
• Other study ID #: PLAGH-TKIs
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 25, 2010
• Last updated: May 26, 2010
• Start date: June 2010
• Est. completion date: June 2015

Study information

• Verified date: April 2010
• Source: Chinese PLA General Hospital
• Contact: Liang-An Chen, MD, phD
• Phone: 86-10-66939361
• Email: chenla301[@]263.net
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Non-Small Cell Lung
• Carcinoma, Non-Small-Cell Lung
• Drug Therapy
• Genes, EGFR
• Lung Neoplasms
• Neoplasms, Lung

Intervention

Drug:
• Erlotinib
Erlotinib 150 mg/d per os until proven disease progression
• Docetaxel
Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment
• Cisplatin
cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment
• Docetaxel
Docetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
• Cisplatin
Cisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
• Erlotinib
Erlotinib 150 mg/d per os as second-line treatment

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		three year	No
Secondary	progression-free survival during the first-line treatment		1 year	No
Secondary	progression-free time during the second-line treatment		2 years	No
Secondary	quality of life during the first-line therapy		every 3 weeks during first-line therapy	No
Secondary	quality of life during the second-line therapy		every 3 weeks during the second-line therapy	No
Secondary	response rates during the first-line treatment		at 6 months from treatment initiation	No
Secondary	response rates during the second-line treatment		every 3 weeks during the treament, and and every 6 weeks thereafter	Yes
Secondary	toxicity during the first-line treatment		at 12 months from treatment initiation	Yes
Secondary	toxicity during the second-line treatment		end of study	Yes
Secondary	preditive and prognostic markers for chemotherapy or erlotinib	tissues for markers analysis are acquired during diagnosis procedure with informed consent.	end of study	No