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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Lung Cancer, Small Cell

Treatments: Drug: Intravenous etoposide/cisplatin; Drug: Intravenous topotecan/cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00320359

104864-A/479

Details and patient eligibility

About

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

Enrollment: 700 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

Arm A

Active Comparator group

Description:

Cisplatin 75 mg/m2 i.v., day 1, Etoposide 100 mg/m2 i.v., days 1-3

Treatment:

Drug: Intravenous etoposide/cisplatin

Arm B

Experimental group

Description:

Topotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5

Treatment:

Drug: Intravenous topotecan/cisplatin