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

Condition(s) targeted: Small Cell Lung Cancer

Intervention: Intravenous topotecan/cisplatin (Drug); Intravenous etoposide/cisplatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, Affiliation: GlaxoSmithKline

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

Official title: An Open-Label, Multicentre, Randomised, Phase III Study Comparing Topotecan/Cisplatin and Topotecan/Etoposide Versus Etoposide/Cisplatin as Treatment for Chemotherapy-Naive Patients With Extensive Disease-Small Cell Lung Cancer

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Overall survival

Secondary outcome: 1 year survival rate, objective response rate, response duration, time to response, time to progression, tolerability, patient-perceived disease status, and well being in each treatment arm

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

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Starting date: May 2002
Last updated: July 17, 2007