A randomised phase 2 study of carboplatin with oral vinorelbine followed by maintenance therapy with oral vinorelbine or erlotinib in elderly patients with metastatic non-small cell lung cancer.

Phase 2

• Conditions: on Small Cell Lung Cancer; Non Small Cell Lung Cancer; Cancer - Lung - Non small cell

• Registration Number: ACTRN12612000473864
• Lead Sponsor: Southern Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified