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A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00606021
Recruitment Status : Completed
First Posted : February 1, 2008
Results First Posted : December 26, 2011
Last Update Posted : December 26, 2011
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:

This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer.

A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).


Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: pemetrexed Drug: Best Supportive Care Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Study Comparing Pemetrexed Plus Best Supportive Care With Best Supportive Care as Maintenance, Following First-Line Treatment With Pemetrexed-Cisplatin, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Study Start Date : January 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: A: Pemetrexed + Best Supportive Care

Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

 Drug: pemetrexed
500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
Other Names:
  • Alimta
  • LY231514

Drug: Best Supportive Care
Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Active Comparator: B: Best Supportive Care
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
 Drug: Best Supportive Care
Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival During Maintenance Phase [ Time Frame: Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months ]
    Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.


Secondary Outcome Measures :
  1. Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP]) [ Time Frame: First dose of study drug during IP to PD or date of death from any cause up to 33.6 months ]
    Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment.

  2. Overall Survival During Maintenance Phase [ Time Frame: Randomization to PD or date of death from any cause up to 31.3 months ]
    Overall survival in maintenance phase is defined as the time from randomization to death. Participants who were alive were censored at the last contact.

  3. Overall Survival During Overall Period (IP + MP) [ Time Frame: First dose of study drug during IP to PD or date of death from any cause up to 34.1 months ]
    Overall survival in overall period is defined as the time from first dose of study drug during IP to death. Participants who were alive were censored at the last contact.

  4. Number of Participants With Adverse Events (AEs) During Overall Period [ Time Frame: First dose of study drug during IP through overall study completion (up to 34.3) months ]
    The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section.

  5. Tumor Response Rate and Disease Control Rate After Induction Phase (IP) [ Time Frame: Randomization to measured PD up to 31.4 months ]
    Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100. Disease control rate is percentage of participants with a best response of stable disease [SD], PR, or CR. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is≥20% increase in sum of longest diameter of target lesions. SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  1. You must be at least 18 years old
  2. You must have been diagnosed with non-squamous non-small cell lung cancer (NSCLC)
  3. You must have had no prior systemic anticancer therapy for lung cancer
  4. You must live close enough to the study doctor to be able to visit regularly for follow up
  5. You must have signed informed consent form indicating your willingness to take part in this study
  6. Your laboratory and medical history and tests must meet study requirements

Exclusion criteria:

  1. Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
  2. Prior radiotherapy and surgery should be completed at least 4 weeks prior to initiation of treatment
  3. Serious concomitant systemic disorder (e.g., active infection including human immunodeficiency virus, or unstable cardiovascular disease)
  4. Prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer unless treated at least 5 years previously with no subsequent evidence of recurrence
  5. Brain metastasis
  6. Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
  7. Significant weight loss (greater than 10%), over the previous 6 weeks before study entry
  8. Concurrent administration of any other antitumor therapy
  9. Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam)
  10. Inability or unwillingness to take folic acid, dexamethasone (or equivalent) or vitamin B12 supplementation
  11. Pregnancy or breast-feeding
  12. You are allergic to pemetrexed
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): NCT00606021


Locations
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Egypt
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.
Assiut, Egypt, 0000
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.
Cairo, Egypt, 11372
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.
Mounofia, Egypt, 32514
Lebanon
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.
Beirut, Lebanon
Saudi Arabia
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.
Riyadh, Saudi Arabia, 11211
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 9am to 5pm Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:

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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00606021    
Other Study ID Numbers: 11839
H3E-EZ-S114 ( Other Identifier: Eli Lilly and Company )
First Posted: February 1, 2008    Key Record Dates
Results First Posted: December 26, 2011
Last Update Posted: December 26, 2011
Last Verified: November 2011
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