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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

Study Description
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Brief Summary:
To determine the response to this regimen for therapy prior surgery in patients with locally advanced disease or metastatic disease.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Drug: pemetrexed Drug: cisplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Alimta (Pemetrexed) and Cisplatin Treatment as Neoadjuvant Therapy in Non Small Cell Lung Cancer
Study Start Date : November 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259285


Locations
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Spain
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.
Barakaldo, Spain, 48903
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.
Barcelona, Spain, 08035
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.
La Coruña, Spain, 15006
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.
Madrid, Spain, 28034
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.
Pamplona, Spain, 31008
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.
Valencia, Spain, 46014
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00259285    
Other Study ID Numbers: 9901
H3E-XM-S092
First Posted: November 29, 2005    Key Record Dates
Results First Posted: June 2, 2009
Last Update Posted: June 2, 2009
Last Verified: April 2009
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors