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

Alimta (Pemetrexed) and Cisplatin Treatment as Neoadjuvant Therapy in Non Small Cell Lung Cancer

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

Study Overview

• Status: Terminated
• Conditions: Non-Small-Cell Lung Cancer
• Intervention / Treatment: Drug: pemetrexed; Drug: cisplatin

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • 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
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Drug: pemetrexed; 500 mg/m2, intravenous (IV), every 21 days x 3 cycles; Other Names: Alimta; LY231514; Drug: cisplatin; 75 mg/m2, intravenous (IV), every 21 days x 3 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Response	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.	every 21 day cycle (3 cycles) and 3-4 weeks after last cycle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic Remissions After Surgery	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.	surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy)
Relapse-free Survival	Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment.	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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: November 28, 2005
• First Submitted That Met QC Criteria: November 28, 2005
• First Posted (Estimate): November 29, 2005

Study Record Updates

• Last Update Posted (Estimate): June 2, 2009
• Last Update Submitted That Met QC Criteria: April 7, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Pemetrexed
• Other Study ID Numbers: 9901; H3E-XM-S092