A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01165021
First received: July 14, 2010
Last updated: July 11, 2013
Last verified: July 2013

July 14, 2010
July 11, 2013
November 2010
July 2013   (final data collection date for primary outcome measure)
Proportion of patients whose response is a complete response (CR) or partial response (PR) [ Time Frame: From study enrollment until disease progression (PD) or recurrence ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01165021 on ClinicalTrials.gov Archive Site
  • Number of patients with no viable tumor cells in resected lung tissue [ Time Frame: At the time of surgery (within 3 to 6 weeks of Day 1 of Cycle 3 of chemotherapy) ] [ Designated as safety issue: No ]
  • Proportion of patients who exhibit a downward shift in tumor extent from stage IIIAN2 to stage IIIA, II, I, or 0 [ Time Frame: After completion of 3 cycles of chemotherapy ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: From study enrollment until the date of death from any cause ] [ Designated as safety issue: No ]
  • Progression-Free Survival [ Time Frame: From study enrollment until the first date of objectively determined Progressive Disease or death from any cause ] [ Designated as safety issue: No ]
  • Number of patients with no viable tumor cells in resected lung tissue [ Time Frame: At the time of surgery (3 to 6 weeks after completion of 3 cycles of chemotherapy) ] [ Designated as safety issue: No ]
  • Proportion of patients who exhibit a downward shift in tumor extent from stage IIIAN2 to stage IIIA, II, I, or 0 [ Time Frame: After completion of 3 cycles of chemotherapy ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: From study enrollment until the date of death from any cause ] [ Designated as safety issue: No ]
  • Progression-Free Survival [ Time Frame: From study enrollment until the first of date of objectively determined Progressive Disease or death from any cause ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer
An Exploratory Phase 2 Study of Pemetrexed/Cisplatin as Pre-operative Chemotherapy in the Treatment of Stage IIIAN2 Nonsquamous Non-Small Cell Lung Cancer

The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • Drug: Pemetrexed
    500 mg/m² administered as an Intravenous infusion on day 1 of 21 day cycle, for 3 cycles
    Other Names:
    • Alimta
    • LY231514
  • Drug: Cisplatin
    75 mg/m² administered as an Intravenous infusion on day 1 of 21 day cycle, for 3 cycles
Experimental: Pemetrexed + Cisplatin
Interventions:
  • Drug: Pemetrexed
  • Drug: Cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
33
March 2016
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Nonsquamous Non Small Cell Lung Cancer that was confirmed by tissue biopsy
  • Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2)
  • Tumor considered potentially resectable
  • Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology Group scale)
  • No prior therapy for lung cancer
  • Measurable disease according to version 1.1 of RECIST Criteria
  • Life expectancy of at least 6 months
  • Organs are functioning well (bone marrow reserve, liver, kidney, lung)
  • Signed Informed Consent
  • Women must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after last dose of study drug; must have a negative pregnancy test within 7 days before study enrollment; and must not be breast-feeding.
  • Men must be surgically sterile,or compliant with a contraceptive regimen during and for 6 months after last dose of study drug.
  • Be fit for surgery at the time of enrollment

Exclusion Criteria:

  • Receiving or have received an investigational drug or device within the last 30 days
  • Have previously completed or withdrawn from this study or any other study investigating pemetrexed
  • Serious concomitant systemic disorder
  • Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
  • Receiving concurrent administration of any other anticancer therapy
  • Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination
  • Inability or unwillingness to take Pemetrexed supplementation/ premedication (folic acid, vitamin B12 , or corticosteroids
  • Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01165021
13621, H3E-EW-JMIP
No
Eli Lilly and Company
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
July 2013

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