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Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by Eli Lilly and Company, March 2009
First Received: August 22, 2007   Last Updated: March 16, 2009   History of Changes
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00520676
  Purpose

The purpose of this study is to compare the combination of pemetrexed and carboplatin with the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4 toxicity in previously untreated patients with locally advanced or metastatic NSCLC.


Condition Intervention Phase
Non-Small Cell Lung Cancer
 Drug: pemetrexed
Drug: docetaxel
Drug: carboplatin
 Phase III

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Docetaxel Pemetrexed Pemetrexed disodium
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 3 Study Comparing Pemetrexed-Carboplatin With Docetaxel-Carboplatin as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To compare a pemetrexed-carboplatin combination with docetaxel-carboplatin in terms of survival without Grade 3 or 4 toxicity in previously untreated patients with locally advanced or metastatic. [ Time Frame: Until patient death or 218 events (defined as death or Grade 3 or 4 toxicity) have been observed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Tumor response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Survival without clinically important Grade 3 or 4 toxicity [ Time Frame: Until patient death or 218 events (defined as death or Grade 3 or 4 toxicity) have been observed ] [ Designated as safety issue: Yes ]
  • Survival without Grade 4 toxicity [ Time Frame: Until patient death or 218 events (defined as death or Grade 3 or 4 toxicity) have been observed ] [ Designated as safety issue: Yes ]
  • Safety and adverse events profile [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 260
Study Start Date: October 2007
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: pemetrexed
500mg/m2, IV, q 21 days x 6 cycles maximum
Drug: carboplatin
AUC 5, IV, q 21 days x 6 cycles maximum
B: Active Comparator Drug: docetaxel
75mg/m2, IV, q 21 days x 6 cycles maximum
Drug: carboplatin
AUC 5, IV, q 21 days x 6 cycles maximum

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior chemotherapy for advanced disease or molecular target treatment
  • ECOG performance status 0 to 2
  • Estimated life expectancy of at least 8 weeks

Exclusion Criteria:

  • Known or suspected brain metastases
  • Concurrent administration of any other tumor therapy
  • Serious concomitant disorders
  • Pregnancy or breast feeding
  • Inability or unwillingness to take folic acid or vitamin B12 supplementation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520676

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

Locations
Australia, Northern Territory
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
Tiwi, Northern Territory, Australia, 0810
Contact: Eli Lilly            
Australia, Victoria
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
Frankston, Victoria, Australia, 3199
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
Wendouree, Victoria, Australia, 3355
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
Ballarat, Victoria, Australia, 3350
Contact: Eli Lilly            
Australia, Western Australia
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
Bunbury, Western Australia, Australia, 6230
Contact: Eli Lilly            
Brazil
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. Active, not recruiting
Barretos, Brazil, 14784700
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. Active, not recruiting
Goiania, Brazil, 74075040
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. Active, not recruiting
Santo André, Brazil, 09060-020
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. Active, not recruiting
São Paulo, Brazil, 01224 010
China
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
Nanjing, China, 210002
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
Shanghai, China, 200032
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
Beijing, China, 100036
Contact: Eli Lilly            
Korea, Republic of
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
Seoul, Korea, Republic of, 138-736
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
Suwon-City, Korea, Republic of, 442-723
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
Ulsan, Korea, Republic of, 682-714
Contact: Eli Lilly            
Mexico
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
Mexicali, Mexico, 21000
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
Mexico City, Mexico, 11640
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
Ciudad Obregon, Mexico, 85100
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
Durango, Mexico, 34208
Contact: Eli Lilly            
Taiwan
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
Taichung, Taiwan, 404
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
Tao-Yuan, Taiwan, 333
Contact: Eli Lilly            
Venezuela
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. Not yet recruiting
Valencia, Venezuela, 2001
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

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

No publications provided

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 11626, H3E-CR-S380
Study First Received: August 22, 2007
Last Updated: March 16, 2009
ClinicalTrials.gov Identifier: NCT00520676     History of Changes
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration;   China: Ethics Committee;   Brazil: National Committee of Ethics in Research;   Korea: Food and Drug Administration;   Mexico: Ethics Committee;   Taiwan: Institutional Review Board

Study placed in the following topic categories:
Antimetabolites
Thoracic Neoplasms
Carboplatin
Folic Acid Antagonists
Carcinoma
Docetaxel
Pemetrexed
 Folic Acid
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Thoracic Neoplasms
Respiratory Tract Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Carboplatin
Folic Acid Antagonists
Pharmacologic Actions
 Carcinoma
Docetaxel
Pemetrexed
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009



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