Clinical trial NCT01196078: A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-09-08
Enrollment: 114
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>=70 years of age
* Non-small cell lung cancer
* Naive to prior chemotherapy or specific immunotherapy
* Presence of at least 1 measurable lesion

Exclusion Criteria:

* Active non-controlled infection or disease
* CNS metastases
* Any other malignancies (other than adequately treated basal cell cancer of skin, or in situ cancer of the cervix)

Primary outcomes:
measure: Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)
timeFrame: Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year
Secondary outcomes:
measure: Percentage of Participants Achieving Disease Control
timeFrame: Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year
measure: Duration of Response Among Participants Who Achieved Either a CR or PR
timeFrame: Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up
measure: Percentage of Participants With Disease Progression
timeFrame: Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death
measure: Time to Disease Progression
timeFrame: Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death
measure: Overall Survival: Percentage of Participants With an Progressive Disease or Death
timeFrame: Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment
measure: Overall Survival: Time to Event
timeFrame: Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment
measure: Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire
timeFrame: Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
measure: Changes in Quality of Life as Measured by the FACT Questionnaire
timeFrame: Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
measure: Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change
timeFrame: Baseline and End of study
measure: Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire
timeFrame: Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
measure: Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change
timeFrame: Baseline and End of study
Other outcomes:
Locations:
city: Taipei
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: