Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer

This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.

Official Title

A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer

Conditions

Small Cell Carcinoma

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

• to compare the overall survival of previously untreated patients with ED-SCLC after treatment with pemetrexed plus carboplatin versus etoposide plus carboplatin

Secondary Outcome Measures:

• subgroup overall survival
• time-to-event variables
• objective tumor response
• changes in dimensions of HRQoL
• the safety and adverse event profile

Study Start

August 2006; Expected completion: March 2010

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• Clinical diagnosis of extensive stage small cell lung cancer
• Capable of self-care but may be unable to carry out any work activities.
• No prior anticancer therapy for SCLC

Exclusion Criteria:

• have previously participated in a study involving pemetrexed
• have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication

Total Enrolment

1820

Contact Details

Australian Locations:New South Wales

• Camperdown, New South Wales, 2050, Australia; Recruiting
• Coffs Harbour, New South Wales, 2450, Australia; Recruiting
• Port Macquarie, New South Wales, 2444, Australia; Recruiting
• Wollongong, New South Wales, 2500, Australia; Recruiting

Queensland

• Chermside, Queensland, 4032, Australia; Recruiting
• Brisbane, Queensland, 4029, Australia; Recruiting
• Redcliffe, Queensland, 4020, Australia; Recruiting
• South Brisbane, Queensland, 4101, Australia; Recruiting
• Townsville, Queensland, 4810, Australia; Recruiting

South Australia

• Adelaide, South Australia, 5000, Australia; Recruiting
• Woodville, South Australia, 5011, Australia; Recruiting

Tasmania

• Hobart, Tasmania, 7001, Australia; Recruiting

Victoria

• Frankston, Victoria, 3199, Australia; Recruiting
• Geelong, Victoria, 3220, Australia; Recruiting
• Wodonga, Victoria, 3690, Australia; Recruiting

For more information, visit the Lilly Clinical Trials Registry