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Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00520676
Recruitment Status : Completed
First Posted : August 24, 2007
Results First Posted : July 18, 2011
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE August 22, 2007
First Posted Date  ICMJE August 24, 2007
Results First Submitted Date  ICMJE June 17, 2011
Results First Posted Date  ICMJE July 18, 2011
Last Update Posted Date August 10, 2011
Study Start Date  ICMJE October 2007
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2011)
Survival Without Grade 3 or 4 Toxicity [ Time Frame: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). ]
Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact.
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2007)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2011)
  • Overall Survival (OS) [ Time Frame: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). ]
    OS is the duration from enrollment to death. For participants who are alive, OS is censored at the last contact.
  • Progression-free Survival (PFS) [ Time Frame: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). ]
    Defined as the time from date of first dose to the first observation of disease progression (PD), or death due to any cause.
  • Percentage of Participants With Tumor Response (Response Rate) [ Time Frame: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). ]
    Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes not meeting above criteria. Response rate (%)=Number of participants with CR+PR/Number of participants analyzed *100. Disease Control rate=Number of participants with SD+PR+CR/Number of participants analyzed *100.
  • Survival Without Clinically Important Grade 3 or 4 Toxicity [ Time Frame: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). ]
    Survival without Grade 3 or 4 toxicity is the time from date of randomization to the first date of the following clinically important Grade 3 or 4 TEAEs graded by the Common Terminology Criteria for Adverse Events [CTCAE], version 3.0: neutropenia (lasting >5 days), febrile neutropenia, documented infections related to neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, and neurosensory events; or death due to any cause. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored for this analysis at the date of last contact.
  • Survival Without Grade 4 Toxicity [ Time Frame: Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (up to 33.3 months). ]
    Survival without Grade 4 toxicity is the time from the date of randomization to the first date of a Grade 4 TEAE or death due to any cause. Participants who are alive without experiencing Grade 4 toxicity will be censored for this analysis at the date of last contact.
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). ]
    Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2007)
  • Overall survival [ Time Frame: Until patient death or 218 events (defined as death or Grade 3 or 4 toxicity) have been observed ]
  • Progression-free survival [ Time Frame: Until patient death or 218 events (defined as death or Grade 3 or 4 toxicity) have been observed ]
  • Tumor response rate [ Time Frame: Until progressive disease ]
  • Duration of response for responding patients [ Time Frame: Until progressive disease ]
  • 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 ]
  • 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 ]
  • Safety and adverse events profile [ Time Frame: Until patient death or 218 events (defined as death or Grade 3 or 4 toxicity) have been observed ]
Current Other Pre-specified Outcome Measures
 (submitted: June 17, 2011)
Duration of Response [ Time Frame: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). ]
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of longest diameter of target lesions.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
Official Title  ICMJE 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
Brief Summary 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 non-small cell lung cancer (NSCLC).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: pemetrexed
    500 mg/m^2, IV, q 21 days x 6 cycles maximum
    Other Names:
    • LY231514
    • Alimta
  • 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
Study Arms  ICMJE
  • Experimental: 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

    Interventions:
    • Drug: pemetrexed
    • Drug: carboplatin
  • Active Comparator: 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

    Interventions:
    • Drug: docetaxel
    • Drug: carboplatin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2007)
260
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior chemotherapy for advanced disease or molecular target treatment
  • Easter Cooperative Oncology Group (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   China,   Korea, Republic of,   Mexico,   Taiwan
Removed Location Countries Venezuela
 
Administrative Information
NCT Number  ICMJE NCT00520676
Other Study ID Numbers  ICMJE 11626
H3E-CR-S380 ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP