Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Vinorelbine

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

Tyrosine

150 mg, orally once a day for up to 6 cycles of 21 days each

erlotinib [Tarceva]

60 mg/m2, orally on days 1 and 8 of cycle 1, 80 mg/m2 for the other cycles

vinorelbine

Clinical Trials

This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study treatment is until disease progression.

A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

A Phase II Randomized Trial of Erlotinib or Vinorelbine in Chemo-naive, Advanced, Non-Small-Cell Lung Cancer Patients Aged 70 Years or Older in Taiwan

CR was defined as disappearance of all target lesions. PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Participants experiencing either a CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) were classified as responders. Participants with tumour assessment unevaluable were viewed as non-responders.

Disease control was defined as achieving a best overall response of CR, PR, or stable disease (SD) according to RECIST criteria. Participants with tumor assessment unevaluable were viewed as uncontrolled.

Duration of response was defined similarly for complete and partial responders. Complete response lasted from the date the complete response was first recorded to the date on which progressive disease was first noted or date of death. Partial response lasted from the date of partial response to the date of the first observation of progressive disease or date of death.

Progressive disease was defined using RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Time to disease progression was defined as the interval between the day of randomization and the first documentation of progressive disease or death.

Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no postbaseline information were censored at the time of randomization. Progressive disease was defined per RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the time of randomization. Overall median time to event was assessed for the population that experienced an event.

The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and the 8-item Lung Cancer Subscale (LCS) that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The FACT-L score ranges from 0 to 136, with higher scores indicating better quality of life.

The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, response of down, up or no change were defined as score changes of less than or equal to (≤)2, greater than or equal to (≥)+2, or between these values.

The FACT and the FACT-L contain 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented Worsened'. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, higher scores indicated a better outcome; a response of down, up, or no change was defined as a score change of ≤ -2 (score down), ≥ +2 (score up), or between these values.

The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition) rated on a five-point scale from 0 (not at all) to 4 (very much). The LCS total score is the sum of the scores from the 7 items. For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The change of FACT-L subscore was the change from baseline to endpoint. The LCS of FACT-L is an independently validated tool that measures the disease-related symptoms of lung cancer on an overall scale of 0 (most symptomatic) to 28 (asymptomatic).

The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items, each rated on a five-point scale from 0 (not at all) to 4 (very much). For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. For each FACT-L question, the response status was defined as down, up, or no change if the score at endpoint was smaller (score down), larger than (score up), or the same as (no change) that at baseline.

Hoffmann-La Roche

Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Erlotinib

Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m\^2 orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m\^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Total

Age, Continuous

Sex: Female, Male

Intent-to-treat (ITT) population: all randomized participants who received at least one dose of study medication.

Medical Communications

Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)

Percentage of Participants Achieving Disease Control

ITT population; only participants with a response (CR or PR) were included in the analysis.

Duration of Response Among Participants Who Achieved Either a CR or PR

Percentage of Participants With Disease Progression

Time to Disease Progression

Overall Survival: Percentage of Participants With an Progressive Disease or Death

Overall Survival: Time to Event

PWB, Baseline (n=56,53)

PWB, Cycle 2 (n=52,42)

PWB, Cycle 3 (n=41,28)

PWB, Cycle 4 (n=37,28)

PWB, Cycle 5 (n=30,22)

PWB, Cycle 6 (n=25,20)

PWB, End of Study (n=52,48)

SWB, Baseline (n=55,53)

SWB, Cycle 2 (n=52,40)

SWB, Cycle 3 (n=42,30)

SWB, Cycle 4 (n=37,27)

SWB, Cycle 5 (n=28,21)

SWB, Cycle 6 (n=26,18)

SWB, End of Study (n=52,47)

EWB, Baseline (n=57,55)

EWB, Cycle 2 (n=52,43)

EWB, Cycle 3 (n=42,29)

EWB, Cycle 4 (n=37,27)

EWB, Cycle 5 (n=29,21)

EWB, Cycle 6 (n=25,20)

EWB, End of Study (n=52,50)

FWB, Baseline (n=56,55)

FWB, Cycle 2 (n=51,41)

FWB, Cycle 3 (n=41,27)

FWB, Cycle 4 (n=37,26)

FWB, Cycle 5 (n=29,22)

FWB, Cycle 6 (n=25,20)

FWB, End of Study (n=51,50)

LCS, Baseline (n=56,54)

LCS, Cycle 2 (n=50,45)

LCS, Cycle 3 (n=42,30)

LCS, Cycle 4 (n=37,27)

LCS, Cycle 5 (n=28,21)

LCS, Cycle 6 (n=26,20)

LCS, End of Study (n=52,50)

Safety Population; n=number of participants assessed for the specified parameter at a given visit.

Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire

PWB, Baseline (n=51,45)

PWB, Endpoint (n=51,45)

Change in PWB (n=51,45)

SWB, Baseline (n=50,45)

SWB, Endpoint (n=50,45)

Change in SWB (n=50,45)

EWB, Baseline (n=52,48)

EWB, Endpoint (n=52,48)

Change in EWB (n=52,48)

FWB, Baseline (n=51,48)

FWB, Endpoint (n=51,48)

Change in FWB (n=51,48)

LCS, Baseline (n=51,47)

LCS, Endpoint (n=51,47)

Change in LCS (n=51,47)

Changes in Quality of Life as Measured by the FACT Questionnaire

PWB, Score Down (n=51,45)

PWB, No Change (n=51,45)

PWB, Score Up (n=51,45)

SWB, Score Down (n=50,45)

SWB, No Change (n=50,45)

SWB, Score Up (n=50,45)

EWB, Score Down (n=52,48)

EWB, No Change (n=52,48)

EWB, Score Up (n=52,48)

FWB, Score Down (n=51,48)

FWB, No Change (n=51,48)

FWB, Score Up (n=51,48)

LCS, Score Down (n=51,47)

LCS, No Change (n=51,47)

LCS, Score Up (n=51,47)

Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change

Shortness of breath, Baseline (n=52,48)

Shortness of breath, Endpoint (n=52,48)

Shortness of breath, Change (n=52,48)

Weight loss, Baseline (n=51,47)

Weight loss, Endpoint (n=51,47)

Weight loss, Change (n=51,47)

Clear thinking, Baseline (n=52,48)

Clear thinking, Endpoint (n=52,48)

Clear thinking, Change (n=52,48)

Coughing, Baseline (n=52,48)

Coughing, Endpoint (n=52,48)

Coughing, Change (n=52,48)

Hair loss, Baseline (n=52,48)

Hair loss, Endpoint (n=52,48)

Hair loss, Change (n=52,48)

Good appetite, Baseline (n=52,48)

Good appetite, Endpoint (n=52,48)

Good appetite, Change (n=52,48)

Tightness in chest, Baseline (n=52,48)

Tightness in chest, Endpoint (n=52,48)

Tightness in chest, Change (n=52,48)

Easy breathing, Baseline (n=52,48)

Easy breathing, Endpoint (n=52,48)

Easy breathing, Change (n=52,48)

Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire

Shortness of breath, Score Down (n=52,48)

Shortness of breath, No Change (n=52,48)

Shortness of breath, Score Up (n=52,48)

Weight loss, Score Down (n=51,47)

Weight loss, No Change (n=51,47)

Weight loss, Score Up (n=51,47)

Clear thinking, Score Down (n=52,48)

Clear thinking No Change (n=52,48)

Clear thinking, Score Up (n=52,48)

Coughing, Score Down (n=52,48)

Coughing, No Change (n=52,48)

Coughing, Score Up (n=52,48)

Hair loss, Score Down (n=52,48)

Hair loss, No Change (n=52,48)

Hair loss, Score Up (n=52,48)

Good appetite, Score Down (n=52,48)

Good appetite, No Change (n=52,48)

Good appetite, Score Up (n=52,48)

Tightness in chest, Score Down (n=52,48)

Tightness in chest, No Change (n=52,48)

Tightness in chest, Score Up (n=52,48)

Easy breathing, Score Down (n=52,48)

Easy breathing, No Change (n=52,48)

Easy breathing, Score Up (n=52,48)

Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change

Participants received erlotinib 150 milligrams (mg), tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 milligrams per square meter (mg/m\^2) orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m\^2 (in the absence of Grade 2 adverse events \[AEs\]) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Overall Study

Spots Global Cancer Trial Database for A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial