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Pemetrexed and Cisplatin Treatment Before Surgery in Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00259285
Recruitment Status : Terminated (Trial was stopped early due to low enrollment.)
First Posted : November 29, 2005
Results First Posted : June 2, 2009
Last Update Posted : June 2, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 28, 2005
First Posted Date  ICMJE November 29, 2005
Results First Submitted Date  ICMJE December 19, 2008
Results First Posted Date  ICMJE June 2, 2009
Last Update Posted Date June 2, 2009
Study Start Date  ICMJE November 2005
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2009)
Treatment Response [ Time Frame: every 21 day cycle (3 cycles) and 3-4 weeks after last cycle ]
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2005)
Lesion measurement in baseline and after the third cycle of treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2009)
  • Pathologic Remissions After Surgery [ Time Frame: surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy) ]
    The status of the pathological response was evaluated on the basis of the original results of the histopathological examination of the tumour samples resected. A complete pathological response was defined as the absence of any viable tumour cell in the tumour samples obtained for histological examination.
  • Relapse-free Survival [ Time Frame: Every 21 day cycle (3 cycles) and then every 3 months for the first 2 years, every 6 months until 5 years have elapsed and annually thereafter ]
    Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2005)
  • Surgical resectability rate,
  • Pathologic remissions rate after surgery
  • toxicity (adverse events)
  • Relapse-free survival
  • Pharmacogenomic determinations and their correlation with the response rate obtained and relapse-free survival
  • Objective response rate using PET and its correlation with the objective response rate obtained using CT and with the pathological response.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pemetrexed and Cisplatin Treatment Before Surgery in Non Small Cell Lung Cancer
Official Title  ICMJE Alimta (Pemetrexed) and Cisplatin Treatment as Neoadjuvant Therapy in Non Small Cell Lung Cancer
Brief Summary To determine the response to this regimen for therapy prior surgery in patients with locally advanced disease or metastatic disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small-Cell Lung Cancer
Intervention  ICMJE
  • Drug: pemetrexed
    500 mg/m2, intravenous (IV), every 21 days x 3 cycles
    Other Names:
    • LY231514
    • Alimta
  • Drug: cisplatin
    75 mg/m2, intravenous (IV), every 21 days x 3 cycles
Study Arms  ICMJE Experimental: A
Interventions:
  • Drug: pemetrexed
  • Drug: cisplatin
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 7, 2009)
10
Original Enrollment  ICMJE
 (submitted: November 28, 2005)
44
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of non-small-cell carcinoma of the lung
  • Patients with locally advanced disease or metastatic disease, candidates to surgery after evaluation by oncologist and thoracic surgeon
  • Tumour with possibility of curative surgery
  • At least one uni-dimensionally measurable lesion
  • Adequate pulmonary function to perform the planned surgical resection

Exclusion Criteria:

  • Active infection (at the investigator's discretion)
  • Pregnancy or breast-feeding
  • Serious concomitant illness at the investigator's discretion
  • Previous diagnosis of malignant disease
  • They have received treatment during the last 30 days with a drug, other than the study drug, that has not received regulatory approval for any indication at the time of their entry in the study
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 Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00259285
Other Study ID Numbers  ICMJE 9901
H3E-XM-S092
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
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM - 5 PM Eastern time (UTC/GMT- 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date April 2009

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