A4061039 Cisplatin/Pemetrexed with or without Axitinib in lung cancer
Randomized phase II study of cisplatin/pemetrexed with or without axitinib (AG-013736) as first line treatment for patients with non-squamous non-small cell lung cancer
More than 1.2 million new cases of lung cancer are diagnosed each year worldwide, with the majority being defined as ??non small cell cancer (NSCLC)?Â. Most patients with NSCLC present with inoperable or metastatic disease for which no curative therapy is available. For these patients, a chemotherapy regimen containing platinum based combinations have become the clinical standard of care. Although pemetrexed (a new drug for NSCLC) and cisplatin (a platinum containing agent) promise the best benefit for a certain subset of patients suffering from?Ânon-squamous NSCLC,?Â a subtype identified by cellular properties, survival still remains unsatisfactory. Axitinib inhibits blood vessel growth, an essential step in cancer development and cancer progression. A previous study in NSCLC has indicated axitinib to be potentially helpful in extending survival. The most common side effects were tiredness, loss of appetite and weight loss, diarrhoea, hypertension and nausea.This study will compare the benefit derived from the treatment of patients with non-squamous NSCLC with a combination of pemetrexed and cisplatin compared to when axitinib is added to the treatment. A first part will expose patients to this drug combination to establish the safety of this regimen. Once established, patients will be randomised to receive axitinib orally twice daily in addition to the two chemotherapy agents which are given up to 6 times intravenously. Furthermore, this study will evaluate two different dosing schedules of axitinib: One group of patients will continue taking axitinib when chemotherapy is given, the other group will pause axitinib for a predefined time period to further evaluate the effect this interruption may have on effect and toxicity.This study is sponsored by Pfizer Inc. and is recruiting patients worldwide.
South West - Cornwall & Plymouth Research Ethics Committee
Date of REC Opinion
30 Jan 2009
Further Information Favourable Opinion