Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00102804
First received: February 1, 2005
Last updated: July 19, 2012
Last verified: June 2012
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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 3 |
| 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:
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: | December 2014 |
| 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:
|
| 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
Show 73 Study LocationsSponsors 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: | 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: | July 19, 2012 |
| 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 May 21, 2013