None listed
Conditions
Brief summary
This study will evaluate the safety and efficacy of induction chemotherapy followed by maintenance with one of the two different drugs in elderly patients with metastatic non-small cell lung cancer. Who is it for? you may be eligible to join this study if you are male or female above 70 years and you have been diagnosed with metastatic non-small cell lung cancer. Trial details All participants will undergo upto 4 x 3 weeks cycles of induction chemotherapy with the drugs vinorelbine (taken as an oral tablet) and carboplatin administered into the vein (intravenously). Participants whose disease has not progressed will then be randomly (by chance) allocated to one of two groups. One group will take a vinorelbine capsule on day 1 and 8 of 3 week cycle. Participants in the other group will take one Erlotinib tablet every day. Participants in both groups will take the treatment till progression of disease, unacceptable side effects or if patient chooses not to continue the treatment. Participants will be assessed every 3-6 weeks until disease progression, death or unacceptable toxicities in order to determine quality of life and response to treatment.
Interventions
Oral Vinorelbine 60mg/m2 on day 1 and day 8 of 21 day cycle for 1st 2 cycles and then escalated to 80mg/m2 on day 1 and day 8 for further 2 cycles if no grade 3 toxicities were noticed, in combination with intravenous carboplatin at a dose calculated according to the formula of Calvert at AUC of 5, on day 1 of 21 day cycle. This induction treatment will be given for up to four cycles. Then maintenance treatment with either oral vinorelbine at dose given at the last cycle of induction therapy o
Oral Vinorelbine 60mg/m2 on day 1 and day 8 of 21 day cycle for 1st 2 cycles and then escalated to 80mg/m2 on day 1 and day 8 for further 2 cycles if no grade 3 toxicities were noticed, in combination with intravenous carboplatin at a dose calculated according to the formula of Calvert at AUC of 5, on day 1 of 21 day cycle. This induction treatment will be given for up to four cycles. Then maintenance treatment with either oral vinorelbine at dose given at the last cycle of induction therapy on day 1 and day 8 of 21 day cycle or Erlotinib 150mg orally continuously every day. The maintenance treatment with vinorelbine or Erlotinib will commence 3 weeks after the last cycle in induction phase of chemotherapy and will continue until documented disease progression, unaccepable toxicities, patient's refusal or investigatior's decision based on the best interests of the patient.
Sponsors
Southern Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients > 70 years old, 2. Histologically or cytologically proven non-small cell lung cancer, 3. Stage 3B (not suitable for radical radiotherapy) or stage 4(7th IALC staging edition), 4. PS 0-1 5. Life expectancy > 12 weeks 6. Adequate bone marrow, hepatic and renal function
Exclusion criteria
1. Known hypersensitivity to drugs with similar chemical structures to study medication, 2. Active CNS disorder, symptomatic brain or leptomeningeal metastasis or CNS disease requiring steroid therapy, 3. Symptomatic neuropathy (sensory) > grade 1 according to the NCI Common Toxicity Criteria, 4. Cardiovascular disease (uncontrolled cardiac failure, or myocardial infraction within the previous 3 months, uncontrolled hypertension or arrhythmia), 5. Active infection requiring i.v. antibiotics within 2 weeks before the beginning of treatment, 6. Superior vena cava syndrome, 7. Long term oxygen therapy, 8. Unstable pleural effusion, 9. Unstable ascites or pericardial effusion, 10. History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix, 11. Radiotherapy within the previous 2 weeks, 12. Concomitant treatment with any other anticancer agent, 13. Uncontrolled hypercalcaemia, 14. Unstable concomitant disease, 15. Concomitant treatment with corticosteroids except chronic treatment ( > 1 month) at low dosing ( < 20 mg/ day of methylprednisolone or equivalent), 16. Significant malabsorption syndrome or disease affecting the gastro-intestinal tract function, 17. Participation to another clinical trial with any investigational drug study (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to study screening.
Outcome results
None listed