Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by Eli Lilly and Company, November 2008
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00606021
  Purpose

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 Intervention Phase
Non Small Cell Lung Cancer
Drug: pemetrexed
Drug: Best Supportive Care
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Cisplatin Pemetrexed disodium Pemetrexed
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: baseline at randomization to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: baseline at randomization to date of death from any cause and at 1 year ] [ Designated as safety issue: Yes ]
  • Safety and adverse events [ Time Frame: Every cycle ] [ Designated as safety issue: Yes ]
  • Tumor response rate & disease control rate after Induction Phase [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Pemetrexed plus Best Supportive Care
Drug: pemetrexed
500 mg/m2 , IV, Day 1 of each 21-day cycle x 6 cycles
Drug: Best Supportive Care
Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
B: Active Comparator
Best Supportive Care
Drug: Best Supportive Care
Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606021

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

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

Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 11839, H3E-EZ-S114
Study First Received: January 17, 2008
Last Updated: November 17, 2008
ClinicalTrials.gov Identifier: NCT00606021  
Health Authority: Egypt: Ministry of Health and Population;   Saudi Arabia: Research Advisory Council;   Lebanon: Institutional Review Board

Study placed in the following topic categories:
Folic Acid
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009