Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
NCT ID: NCT00520676
Last Updated: 2011-08-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
260 participants
INTERVENTIONAL
2007-10-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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pemetrexed plus carboplatin
Drug: pemetrexed 500 milligrams per square meter (mg/m\^2), intravenous (IV), every (q) 21 days x 6 cycles maximum
Drug: carboplatin Area Under the Curve (AUC) 5 milligram\*minute/milliLiter (mg\*min/mL), IV, q 21 days x 6 cycles maximum
pemetrexed
500 mg/m\^2, IV, q 21 days x 6 cycles maximum
carboplatin
AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum
docetaxel plus carboplatin
Drug: docetaxel 75 mg/m\^2, IV, q 21 days x 6 cycles maximum
Drug: carboplatin AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum
docetaxel
75 mg/m\^2, IV, q 21 days x 6 cycles maximum
carboplatin
AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum
Interventions
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pemetrexed
500 mg/m\^2, IV, q 21 days x 6 cycles maximum
docetaxel
75 mg/m\^2, IV, q 21 days x 6 cycles maximum
carboplatin
AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Easter Cooperative Oncology Group (ECOG) performance status 0 to 2
* Estimated life expectancy of at least 8 weeks
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly and Company
Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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.
Ballarat, Victoria, 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.
Frankston, Victoria, 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.
Wendouree, Victoria, 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.
Bunbury, Western Australia, Australia
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Barretos, , Brazil
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Goiânia, , Brazil
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Santo André, , Brazil
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São Paulo, , Brazil
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Beijing, , China
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Nanjing, , China
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Shanghai, , China
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Ciudad Obregón, , Mexico
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Durango, , Mexico
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Mexicali, , Mexico
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Mexico City, , Mexico
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Seoul, , South Korea
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.
Suwon, , South Korea
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.
Ulsan, , South Korea
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.
Taichung, , 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.
Taoyuan District, , Taiwan
Countries
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References
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Loureiro H, Kolben TM, Kiermaier A, Ruttinger D, Ahmidi N, Becker T, Bauer-Mehren A. Correlation Between Early Trends of a Prognostic Biomarker and Overall Survival in Non-Small-Cell Lung Cancer Clinical Trials. JCO Clin Cancer Inform. 2023 Sep;7:e2300062. doi: 10.1200/CCI.23.00062.
Pereira JR, Cheng R, Orlando M, Kim JH, Barraclough H. Elderly subset analysis of randomized phase III study comparing pemetrexed plus carboplatin with docetaxel plus carboplatin as first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer. Drugs R D. 2013 Dec;13(4):289-96. doi: 10.1007/s40268-013-0032-6.
Other Identifiers
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H3E-CR-S380
Identifier Type: OTHER
Identifier Source: secondary_id
11626
Identifier Type: -
Identifier Source: org_study_id
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