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

NCT01131429 | Unknown Phase 2 DMC

• 1 other identifier: PLAGH-TKIs
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 .

Conditions

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

Keywords

mutation analysis; first-line; second-line; targeted therapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  three year

Secondary Outcomes (9)

• progression-free survival during the first-line treatment

  1 year

• progression-free time during the second-line treatment

  2 years

• quality of life during the first-line therapy

  every 3 weeks during first-line therapy

• quality of life during the second-line therapy

  every 3 weeks during the second-line therapy

• response rates during the first-line treatment

  at 6 months from treatment initiation

Study Arms (2)

first-line erlotinib

EXPERIMENTAL

erlotinib in first-line treatment and docetaxel/cisplatin in second-line treatment

Drug: Erlotinib; Drug: Docetaxel; Drug: Cisplatin

second-line erlotinib

ACTIVE COMPARATOR

docetaxel/cisplatin in first-line treatment and erlotinib in second-line treatment

Drug: Docetaxel; Drug: Cisplatin; Drug: Erlotinib

Interventions

Erlotinib DRUG

Erlotinib 150 mg/d per os until proven disease progression

first-line erlotinib

Docetaxel DRUG

Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment

first-line erlotinib

Cisplatin DRUG

cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment

first-line erlotinib

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Liang-An Chen, M.D., Ph.D.

  Chinese PLA General Hospital, Beijing, China

  STUDY CHAIR

Central Study Contacts

Liang-An Chen, MD, phD

CONTACT

86-10-66939361; chenla301@263.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: May 27, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2015
• Last Updated: May 27, 2010

Record last verified: 2010-04

Locations

CN (1)