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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00363415
First received: August 10, 2006
Last updated: October 20, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Cancer
Drug: pemetrexed
Drug: etoposide
Drug: carboplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: baseline to date of death from any cause (up to 19.6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (Subgroups) [ Time Frame: baseline to date of death from any cause (up to 19.6 months) ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: baseline to measured progressive disease (up to 14.7 months) ] [ Designated as safety issue: No ]
  • Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L) [ Time Frame: baseline and 6 cycles (21-day cycles) ] [ Designated as safety issue: No ]
  • Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes) [ Time Frame: baseline to date of death due to any cause (up to 19.6 months) ] [ Designated as safety issue: No ]

Enrollment: 908
Study Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
Other Names:
  • LY231514
  • Alimta
Drug: carboplatin
Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
Active Comparator: B Drug: etoposide
100 mg/m2, intravenous (IV), days 1-3 x 6 cycles
Drug: carboplatin
Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of extensive stage small cell lung cancer (SCLC)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363415

  Show 190 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00363415     History of Changes
Other Study ID Numbers: 9691, H3E-MC-JMHO
Study First Received: August 10, 2006
Results First Received: June 5, 2009
Last Updated: October 20, 2009
Health Authority: European Union: European Medicines Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide
Etoposide phosphate
Pemetrexed
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Folic Acid Antagonists

ClinicalTrials.gov processed this record on August 25, 2014