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

Phase 3CompletedNCT00320359

GlaxoSmithKline700 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

700

Conditions

Lung Cancer, Small Cell

Interventions

Intravenous topotecan/cisplatinDRUG

Topotecan 1 mg/m2 should be administered intravenously over a period of 30 minutes on days 1-5. Then a 30 minute saline flush should be administered followed by the cisplatin on day 5. Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 5 after topotecan.

Intravenous etoposide/cisplatinDRUG

Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 1. Cisplatin should be given simultaneously to post-hydration to ensure a high volume fluid. Etoposide 100 mg/m2 should be administered after cisplatin intravenously over a period not less than 30 minutes on days 1 -3.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.