Back to resultsA Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.
Primary Purpose
Non-Squamous Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Erlotinib
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable disease ;
- ECOG PS 2;
- adequate organ function.
Exclusion Criteria:
- prior chemotherapy or systemic anti-tumor therapy;
- hypersensitivity to erlotinib;
- any condition contraindicating the use of the study medication and/or impairing the interpretation of results and/or leading to treatment-related complications.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Erlotinib + Gemcitabine
Gemcitabine
Arm Description
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
Outcomes
Primary Outcome Measures
Progression Free Survival
Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.
Secondary Outcome Measures
Objective Response Rate
Objective response rate was defined as the percentage of participants who have any evidence of confirmed objective of complete response (CR) + partial response (PR), as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD.
Disease Control Rate
Disease control rate was defined as the percentage of participants who have any evidence of confirmed objective CR or PR or Stable disease (SD) (where SD was maintained for 8 weeks), as assessed by the RECIST version 1.0 criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of the LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of the LD since the treatment started. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions.
Duration of Response
Duration of response was defined as the interval between the date of CR or PR was first recorded to the date on which progressive disease was first noted or date of death.
Overall Survival
Overall survival was defined as the interval between the date of randomization to the date of death from any cause.
Mean Change in Pulse Rate From Baseline
Mean change in pulse rate from Baseline for each cycle calculated as Day 1 of each cycle value minus Baseline value
Mean Change in Blood Pressure From Baseline
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded as vital parameters in this study. Mean change in SBP and DBP from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.
Mean Change in Body Temperature From Baseline
Mean change in body temperature from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00518011
Brief Title
A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.
Official Title
A Randomized, Open Label Study Comparing the Effect of First-line Therapy With Tarceva + Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve Patients With Advanced Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Squamous Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erlotinib + Gemcitabine
Arm Type
Experimental
Arm Description
Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
Arm Title
Gemcitabine
Arm Type
Active Comparator
Arm Description
Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Intervention Description
150 mg po daily
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
As prescribed
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
Objective response rate was defined as the percentage of participants who have any evidence of confirmed objective of complete response (CR) + partial response (PR), as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD.
Time Frame
Up to 2 years
Title
Disease Control Rate
Description
Disease control rate was defined as the percentage of participants who have any evidence of confirmed objective CR or PR or Stable disease (SD) (where SD was maintained for 8 weeks), as assessed by the RECIST version 1.0 criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of the LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of the LD since the treatment started. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame
Up to 2 years
Title
Duration of Response
Description
Duration of response was defined as the interval between the date of CR or PR was first recorded to the date on which progressive disease was first noted or date of death.
Time Frame
Up to 2 years
Title
Overall Survival
Description
Overall survival was defined as the interval between the date of randomization to the date of death from any cause.
Time Frame
Up to 2 years
Title
Mean Change in Pulse Rate From Baseline
Description
Mean change in pulse rate from Baseline for each cycle calculated as Day 1 of each cycle value minus Baseline value
Time Frame
Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)
Title
Mean Change in Blood Pressure From Baseline
Description
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded as vital parameters in this study. Mean change in SBP and DBP from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.
Time Frame
Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)
Title
Mean Change in Body Temperature From Baseline
Description
Mean change in body temperature from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.
Time Frame
Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >=18 years of age;
non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable disease ;
ECOG PS 2;
adequate organ function.
Exclusion Criteria:
prior chemotherapy or systemic anti-tumor therapy;
hypersensitivity to erlotinib;
any condition contraindicating the use of the study medication and/or impairing the interpretation of results and/or leading to treatment-related complications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Auchenflower
ZIP/Postal Code
4066
Country
Australia
City
Chermside
ZIP/Postal Code
4032
Country
Australia
City
Footscray
ZIP/Postal Code
3011
Country
Australia
City
Greenslopes
ZIP/Postal Code
4120
Country
Australia
City
Lismore
ZIP/Postal Code
2480
Country
Australia
City
Melbourne
ZIP/Postal Code
3002
Country
Australia
City
Melbourne
ZIP/Postal Code
3084
Country
Australia
City
Parkville
ZIP/Postal Code
3052
Country
Australia
City
Randwick
ZIP/Postal Code
2031
Country
Australia
City
Richmond
ZIP/Postal Code
3121
Country
Australia
City
St. Leonards
ZIP/Postal Code
2065
Country
Australia
City
Sydney
ZIP/Postal Code
2139
Country
Australia
City
Wodonga
ZIP/Postal Code
3690
Country
Australia
City
Wollongong
ZIP/Postal Code
2500
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.
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