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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

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

U.S. FDA Resources

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

Additional Information:

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

No publications provided

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 History of Changes
Health Authority:	European Union: European Medicines Agency; United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Folate
Carboplatin
Folinic Acid
Folic Acid Antagonists
Etoposide phosphate
Vitamin B9
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
Antineoplastic Agents, Phytogenic
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Thoracic Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Etoposide phosphate
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Etoposide
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Enzyme Inhibitors
Carboplatin
Folic Acid Antagonists
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Pemetrexed
Neuroectodermal Tumors
Neoplasms
Lung Diseases
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 02, 2009