Study of Amrubicin With or Without Cisplatin Versus Etoposide-cisplatin for Extensive Stage Small Cell Lung Cancer

Randomized Phase II Study of Amrubicin as Single Agent or in Combination With Cisplatin Versus Etoposide-cisplatin as First-line Treatment in Patients With Extensive Stage SCLC (ES)

The purpose of the study is to document the activity and safety of single agent amrubicin, amrubicin combined with cisplatin, and etoposide combined with cisplatin as first-line treatment in extensive disease small cell lung cancer.

Inclusion Criteria:

• Histologically/cytologically proven small cell lung cancer
• Extensive disease
• Measurable disease
• World Health Organization (WHO) performance status 0-2
• Age 18 years or older
• Normal baseline cardiac function
• No prior systemic chemotherapy for small cell lung cancer
• Adequate organ function including bone marrow, kidney, and liver
• No history of interstitial lung disease or pulmonary fibrosis
• No history of prior malignancy unless patient has been disease free for greater than 5 years, or the tumour was a non-melanoma skin cancer or in-situ carcinoma of the cervix
• No pregnancy or breast feeding; patients of child-bearing potential must agree to use an appropriate method of contraception
• Written informed consent before randomization

Exclusion criteria:

• Pre-existing peripheral neuropathy (greater than Grade 1, CTCAE version 3.0)
• Uncontrolled or severe cardiovascular disease
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule