Active Symptom Control Alone Or In Combination With Oral Topotecan In Patients With Relapsed Resistant Small Cell Lung Cancer

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Lung Cancer, Small Cell

Treatments: Drug: topotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00276276

104864/478

Details and patient eligibility

About

The purpose of this study is to find out if giving oral HYCAMTIN to patients with relapsed small cell lung cancer benefits them. The study will compare how long patients live when they are given therapy to make them feel better (active symptom control) to the length of time patients live when they are also receiving oral HYCAMTIN.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Received one prior chemotherapy regimen only.
• Documented partial or complete response to first-line therapy.
• Documented relapse of limited or extensive SCLC at least 45 days after the cessation of first-line chemotherapy.
• Not considered suitable for further intravenous chemotherapy.
• Considered to have adequate bone marrow reserve.
• Performance Status of 0, 1 or 2.

Exclusion criteria

• Pregnant or lactating.
• Received more than one prior regimen of chemotherapy.
• Uncontrolled vomiting.
• Brain metastases.
• Active uncontrolled infection.
• Received previous treatment with HYCAMTIN.
• Received an investigational product within 30 days.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)