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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00518011
Registration number
NCT00518011
Ethics application status
Date submitted
16/08/2007
Date registered
17/08/2007
Date last updated
16/05/2016
Titles & IDs
Public title
A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.
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Scientific 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
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Secondary ID [1]
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ML20063
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Squamous Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Erlotinib
Treatment: Drugs - Gemcitabine
Experimental: Erlotinib + Gemcitabine - 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.
Active Comparator: Gemcitabine - Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
Treatment: Drugs: Erlotinib
150 mg po daily
Treatment: Drugs: Gemcitabine
As prescribed
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 2 years
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Secondary outcome [1]
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Objective Response Rate
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 2 years
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Secondary outcome [2]
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Disease Control Rate
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 2 years
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Secondary outcome [3]
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Duration of Response
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 2 years
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Secondary outcome [4]
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Overall Survival
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Assessment method [4]
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Overall survival was defined as the interval between the date of randomization to the date of death from any cause.
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Timepoint [4]
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Up to 2 years
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Secondary outcome [5]
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Mean Change in Pulse Rate From Baseline
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Assessment method [5]
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Mean change in pulse rate from Baseline for each cycle calculated as Day 1 of each cycle value minus Baseline value
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Timepoint [5]
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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)
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Secondary outcome [6]
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Mean Change in Blood Pressure From Baseline
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Assessment method [6]
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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.
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Timepoint [6]
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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)
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Secondary outcome [7]
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Mean Change in Body Temperature From Baseline
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Assessment method [7]
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Mean change in body temperature from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.
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Timepoint [7]
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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)
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2009
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Sample size
Target
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Accrual to date
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Final
17
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Auchenflower
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Recruitment hospital [2]
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- Chermside
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Recruitment hospital [3]
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- Footscray
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Recruitment hospital [4]
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- Greenslopes
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Recruitment hospital [5]
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- Lismore
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Recruitment hospital [6]
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- Melbourne
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Recruitment hospital [7]
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- Parkville
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Recruitment hospital [8]
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- Randwick
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Recruitment hospital [9]
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- Richmond
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Recruitment hospital [10]
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- St. Leonards
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Recruitment hospital [11]
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- Sydney
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Recruitment hospital [12]
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- Wodonga
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Recruitment hospital [13]
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- Wollongong
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Recruitment postcode(s) [1]
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4066 - Auchenflower
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Recruitment postcode(s) [2]
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4032 - Chermside
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Recruitment postcode(s) [3]
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3011 - Footscray
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Recruitment postcode(s) [4]
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4120 - Greenslopes
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Recruitment postcode(s) [5]
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2480 - Lismore
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Recruitment postcode(s) [6]
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3002 - Melbourne
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Recruitment postcode(s) [7]
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3084 - Melbourne
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Recruitment postcode(s) [8]
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3052 - Parkville
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Recruitment postcode(s) [9]
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2031 - Randwick
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Recruitment postcode(s) [10]
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3121 - Richmond
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Recruitment postcode(s) [11]
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2065 - St. Leonards
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Recruitment postcode(s) [12]
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2139 - Sydney
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Recruitment postcode(s) [13]
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3690 - Wodonga
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Recruitment postcode(s) [14]
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2500 - Wollongong
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00518011
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00518011
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