Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by (Responsible Party):	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00102804

Purpose

This study is a randomized Phase 3, double-blind study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care in Non Small Cell Lung Cancer (NSCLC). Patients must have received one of six induction regimens for 4 cycles and did not have progressive disease prior to randomization (enrollment) into this trial.

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Drug: pemetrexed Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment for Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Progression-free survival time (PFS) [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival time (OS) [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
Time to objective progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Time to worsening of symptoms [ Time Frame: baseline to stopping treatment ] [ Designated as safety issue: Yes ]
Objective tumor response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Changes in individual symptom scores and quality of life using the Lung Cancer Symptoms Scale (LCSS) [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	660
Study Start Date:	March 2005
Estimated Study Completion Date:	June 2012
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: pemetrexed 500 mg/m2, IV, q 21 days, until disease progression Other Names: LY231514 Alimta
Placebo Comparator: B	Drug: Placebo IV, q 21 days

Eligibility

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

Criteria

Inclusion Criteria:

Histologic or cytologic diagnosis of NSCLC Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or Stage IV prior to induction therapy.
Patients must have had one of the following induction therapies for treatment for Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV NSCLC: Gemcitabine plus carboplatin, paclitaxel plus carboplatin, or docetaxel plus carboplatin, gemcitabine plus cisplatin, paclitaxel plus cisplatin or docetaxel plus cisplatin.
Patients must have received only one chemotherapeutic doublet lasting precisely four cycles.
Induction regimens must be based on 21-day cycles.
Documented evidence of a tumor response of CR, PR or SD. Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. This response does not have to be confirmed in order for the patient to be randomized. (Positron emission tomography (PET) scans and ultrasounds may not be used for lesion measurements for response determination.

Exclusion Criteria:

With the exception of those chemotherapies listed as inclusion criterion, patients will not be included if they have received prior systemic anticancer therapy (including adjuvant early-stage treatment for NSCLC) or any systemic treatment for any other cancer.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Inability to comply with protocol or study procedures.
A serious concomitant systemic disorder that would compromise the patient's ability to complete the study.
A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102804

Show 73 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 by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ciuleanu T, Brodowicz T, Zielinski C, Kim JH, Krzakowski M, Laack E, Wu YL, Bover I, Begbie S, Tzekova V, Cucevic B, Pereira JR, Yang SH, Madhavan J, Sugarman KP, Peterson P, John WJ, Krejcy K, Belani CP. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet. 2009 Oct 24;374(9699):1432-40. Epub 2009 Sep 18.

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00102804 History of Changes
Other Study ID Numbers:	5122, H3E-MC-JMEN
Study First Received:	February 1, 2005
Last Updated:	December 15, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on February 09, 2012