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A Comparison of Two Doses of Pemetrexed in Patients Who Have Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00078260
Recruitment Status : Completed
First Posted : February 24, 2004
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:

The purposes of this study are to determine:

  • the safety of pemetrexed and any side effects that might be associated with it
  • how much pemetrexed should be given to patients.

It is possible that information collected during this study will be analyzed by the Sponsor in the future to evaluate pemetrexed for other possible uses or for other medical or scientific purposes other than those currently proposed.

Although pemetrexed has been shown to be effective in some patients with non-small-cell lung cancer, pemetrexed might not have beneficial effects for all patients.


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: pemetrexed Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 589 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 3 Study of Two Doses of Alimta in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed a Prior Platinum-Containing Chemotherapy
Study Start Date : December 2003
Actual Primary Completion Date : October 2006
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: A Drug: pemetrexed

A: 500 mg/m2, IV, q 21 days until disease progression

B: 900 mg/m2, IV, q 21 days until disease progression
Experimental: B Drug: pemetrexed

A: 500 mg/m2, IV, q 21 days until disease progression

B: 900 mg/m2, IV, q 21 days until disease progression


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: baseline to date of death from any cause ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: baseline to measured progressive disease ]
  2. Tumor response rate [ Time Frame: baseline to measured progressive disease ]
  3. Adverse events [ Time Frame: every cycle ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) that is not amenable to curative therapy.
  • Patients must have been previously treated with one platinum-containing chemotherapy regimen for locally advanced or metastatic disease. Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional chemotherapy regimen upon recurrence.
  • No more than two prior systemic anti-cancer therapies will be allowed.
  • Prior radiation therapy is allowed to less than 25% of the bone marrow. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment.

Exclusion Criteria:

  • Pregnancy.
  • Breast-feeding.
  • Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
  • Inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a 5-day period.
  • Inability or unwillingness to take folic acid or vitamin B12 supplementation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00078260


Locations
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Turkey
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ankara, Turkey
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gaziantep, Turkey
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Additional Information:

Publications of Results:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00078260    
Other Study ID Numbers: 8433
H3E-MC-JMGX ( Other Identifier: Eli Lilly and Company )
First Posted: February 24, 2004    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors