Expired Study
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Memphis, Tennessee 38120


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.


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.


Study is Available At:


Original ID:

5122


NCT ID:

NCT00102804


Secondary ID:

H3E-MC-JMEN


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eli Lilly and Company


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

660


Enrollment Type:

Anticipated


Overall Contact Information

Official Name: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)
Study Director
Eli Lilly and Company

Study Dates

Start Date:March 2005
Completion Date:December 2013
Completion Type:Actual
Primary Completion Date:August 2007
Primary Completion Type:Actual
Verification Date:June 2012
Last Changed Date:December 11, 2013
First Received Date:February 1, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Changes in individual symptom scores and quality of life using the Lung Cancer Symptoms Scale (LCSS)
Time Frame:every cycle
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Adverse events
Time Frame:every cycle
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Objective tumor response rate
Time Frame:baseline to measured progressive disease
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to worsening of symptoms
Time Frame:baseline to stopping treatment
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Time to objective progressive disease
Time Frame:baseline to measured progressive disease
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Overall survival time (OS)
Time Frame:baseline to date of death from any cause
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Progression-free survival time (PFS)
Time Frame:baseline to measured progressive disease
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:pemetrexed
Description:500 mg/m2, IV, q 21 days, until disease progression
Arm Name:A
Other Name:LY231514
Intervention Type:Drug
Name:Placebo
Description:IV, q 21 days
Arm Name:B

Study Arms

Study Arm Type:Experimental
Arm Name:A
Study Arm Type:Placebo Comparator
Arm Name:B

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Eli Lilly and Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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