Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Eligibility Criteria

Inclusion Criteria:

• Histologically/cytologically proven small cell lung cancer

• Extensive disease

• Measurable disease

• 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Celgene Corporation

Mary O'Brien, MD

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00388960
Information obtained from ClinicalTrials.gov on December 14, 2011

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