Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Cisplatin; Etoposide; Etoposide phosphate; Topotecan

Criteria

Inclusion Criteria:

• Evaluable extensive small cell lung cancer, extensive disease.

• Eastern Cooperative Oncology Group (ECOG) performance status < 2.

• Life expectancy > 3 months.

• Fit to receive any of the treatments.

• No prior chemotherapy.

• Written informed consent.

Exclusion Criteria:

• Extensive disease treatable with radiotherapy.

• Past or current history of other malignant disease.

• Prior chemotherapy.

• Pregnancy, lactating or lack of effective contraception.

• Concurrent severe medical problems other than small cell lung cancer.

• Patients with central nervous system metastases receiving more than 12 mg /day dexamethasone or equivalent to control symptoms.