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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Amrubicin; Cisplatin; Etoposide; Etoposide phosphate

Criteria

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