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

Phase 2

Terminated

• Conditions: Non-Small-Cell Lung Cancer
• Interventions: Drug: pemetrexed; Drug: cisplatin

• Registration Number: NCT00259285
• Lead Sponsor: Eli Lilly and Company

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 available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-28
• Study First Submitted QC: 2005-11-28
• Study First Posted: 2005-11-29
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2008-12-19
• Status Verified: 2009-04
• Results First Submitted QC: 2009-04-07
• Last Update Submitted: 2009-04-07
• Results First Posted: 2009-06-02
• Last Update Posted: 2009-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	cisplatin	-
A	pemetrexed	-

Primary Outcome Measures

Name	Time	Method
Treatment Response	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

Name	Time	Method
Pathologic Remissions After Surgery	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	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.

Trial Locations

Locations (1)

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