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
Overview
- Phase
- Phase 4
- Intervention
- erlotinib [Tarceva]
- Conditions
- Non-Small Cell Lung Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 114
- Primary Endpoint
- Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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)
Arms & Interventions
1
Intervention: erlotinib [Tarceva]
2
Intervention: vinorelbine
Outcomes
Primary Outcomes
Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)
Time Frame: Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year
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.
Secondary Outcomes
- Duration of Response Among Participants Who Achieved Either a CR or PR(Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up)
- Time to Disease Progression(Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death)
- Overall Survival: Time to Event(Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment)
- Changes in Quality of Life as Measured by the FACT Questionnaire(Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study)
- Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire(Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study)
- Percentage of Participants Achieving Disease Control(Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year)
- Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change(Baseline and End of study)
- Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change(Baseline and End of study)
- Percentage of Participants With Disease Progression(Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death)
- Overall Survival: Percentage of Participants With an Progressive Disease or Death(Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment)
- Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire(Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study)