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

Primary Purpose

Neoplasms, Lung, Carcinoma, Non-Small Cell Lung, Drug Therapy

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Erlotinib

Docetaxel

Cisplatin

Docetaxel

Cisplatin

Erlotinib

About this trial

This is an interventional treatment trial for Neoplasms, Lung focused on measuring mutation analysis, first-line, second-line, targeted therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

first-line erlotinib

second-line erlotinib

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

progression-free survival during the first-line treatment

progression-free time during the second-line treatment

quality of life during the first-line therapy

quality of life during the second-line therapy

response rates during the first-line treatment

response rates during the second-line treatment

toxicity during the first-line treatment

toxicity during the second-line treatment

preditive and prognostic markers for chemotherapy or erlotinib

tissues for markers analysis are acquired during diagnosis procedure with informed consent.

Full Information

NCT ID

NCT01131429

First Posted

May 25, 2010

Last Updated

May 26, 2010

Sponsor

Chinese PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01131429

Brief Title

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

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Unknown status

Study Start Date

June 2010 (undefined)

Primary Completion Date

June 2013 (Anticipated)

Study Completion Date

June 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

first-line erlotinib

Arm Type

Experimental

Arm Description

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

Arm Title

second-line erlotinib

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Erlotinib

Intervention Description

Erlotinib 150 mg/d per os until proven disease progression

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

Docetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Cisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most

Intervention Type

Drug

Intervention Name(s)

Erlotinib

Intervention Description

Erlotinib 150 mg/d per os as second-line treatment

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

three year

Secondary Outcome Measure Information:

Title

progression-free survival during the first-line treatment

Time Frame

1 year

Title

progression-free time during the second-line treatment

Time Frame

2 years

Title

quality of life during the first-line therapy

Time Frame

every 3 weeks during first-line therapy

Title

quality of life during the second-line therapy

Time Frame

every 3 weeks during the second-line therapy

Title

response rates during the first-line treatment

Time Frame

at 6 months from treatment initiation

Title

response rates during the second-line treatment

Time Frame

every 3 weeks during the treament, and and every 6 weeks thereafter

Title

toxicity during the first-line treatment

Time Frame

at 12 months from treatment initiation

Title

toxicity during the second-line treatment

Time Frame

end of study

Title

preditive and prognostic markers for chemotherapy or erlotinib

Description

tissues for markers analysis are acquired during diagnosis procedure with informed consent.

Time Frame

end of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liang-An Chen, MD, phD

Phone

86-10-66939361

chenla301@263.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liang-An Chen, M.D., Ph.D.

Organizational Affiliation

Chinese PLA General Hospital, Beijing, China

Official's Role

Study Chair

Facility Information:

Facility Name

Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liang-An Chen, MD, phD

Phone

86-10-66939361

chenla301@263.net

First Name & Middle Initial & Last Name & Degree

Liang-An Chen, MD, phD

12. IPD Sharing Statement

Learn more about this trial

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

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