Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00391274
First received: October 19, 2006
Last updated: April 8, 2011
Last verified: April 2011

October 19, 2006
April 8, 2011
October 2006
December 2008   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment) ] [ Designated as safety issue: Yes ]
Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.
To compare overall survival in patients treated with pemetrexed or docetaxel
Complete list of historical versions of study NCT00391274 on ClinicalTrials.gov Archive Site
  • Overall Tumor Response [ Time Frame: baseline to measured tumor response (up to 24 months after study enrollment) ] [ Designated as safety issue: No ]
    Response based on Response Evaluation Criteria In Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions; SD (stable disease) = small changes that do not meet above criteria.
  • Progression-Free Survival (PFS) [ Time Frame: baseline to measured progressive disease (up to 24 months after study enrollment) ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) time was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause. For patients who were alive and had not progressed, PFS was censored at the last contact.
  • Duration of Response [ Time Frame: time of response to progressive disease (up to 24 months) ] [ Designated as safety issue: No ]
    Duration of tumor response is the duration from date of first objective status assessment of a complete or partial response to the first date of progression or death from any cause. For each patient who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, duration of tumor response was censored at the time of last prior contact. Due to the low number of patients in the analysis, the median duration of tumor response could not be calculated for the docetaxel arm. Available data are presented as "Number of Patients with Disease Progression".
  • Pharmacology Toxicity [ Time Frame: first dose of study drug up to 24 months ] [ Designated as safety issue: Yes ]
    Maximum common terminology criteria (CTC) Grade 3 or 4 toxicities possibly related to study drug are reported. The worst grade event per cycle is reported. Grades range from 0 (none) to 5 (death). Grade 3 events are severe and Grade 4 events are life-threatening.
  • To compare tumor response rate, progression-free survival, duration of response
  • To compare quantitative and qualitative toxicities of both therapies
  • To compare changes in the average symptom burden index between pemetrexed and docetaxel arms using the Lung Cancer Symptom Scale (LCSS).
Not Provided
Not Provided
 
Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
Phase 3 Study of Pemetrexed Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy

The purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel administered on a 3-weekly schedule in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have had prior chemotherapy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: pemetrexed
    500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment
    Other Names:
    • LY231514
    • Alimta
  • Drug: docetaxel
    75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment
  • Experimental: Pemetrexed
    Intervention: Drug: pemetrexed
  • Active Comparator: Docetaxel
    Intervention: Drug: docetaxel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
June 2010
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologic or cytologic diagnosis NSCLC (Stage IIIA, IIIB, or IV), not amenable to curative surgery or radiotherapy
  • At least one prior chemotherapy for palliative therapy
  • Response Evaluation Criteria In Solid Tumors (RECIST) criteria for disease status assessment
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Exclusion Criteria:

  • Concurrent administration of any other tumor therapy
  • Pregnant or breast feeding
  • Serious concomitant disorders
  • Inability or unwillingness to take folic acid or vitamin B12 supplementation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00391274
10717, H3E-MC-JMID
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
April 2011

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