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

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00363415

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 III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Etoposide Pemetrexed disodium Pemetrexed Etoposide phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall survival (subgroup) [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: No ]
Progression free survival [ Time Frame: baseline measured progressive disease ] [ Designated as safety issue: No ]
Quality of life and adverse events [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Enrollment:	958
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
A: Experimental	Drug: pemetrexed 500 mg/m2, IV, q 21 days x 6 cycles Drug: carboplatin AUC 5, IV, q 21 days x 6 cycles
B: Active Comparator	Drug: etoposide 100 mg/m2, IV, days 1-3 x 6 cycles Drug: carboplatin AUC 5, IV, q 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
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

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

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	9691, H3E-MC-JMHO
Study First Received:	August 10, 2006
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00363415
Health Authority:	European Union: European Medicines Agency; United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Carboplatin
Etoposide phosphate
Carcinoma
Neuroendocrine Tumors
Folic Acid
Pemetrexed
Carcinoma, Small Cell

Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue

Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009