Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Pemetrexed - Before Protocol Amendment; Drug: Pemetrexed - After Protocol Amendment

• Registration Number: NCT00370292
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to monitor the blood values of these biomolecules at different time intervals, to optimize the synergism between pemetrexed and gemcitabine.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-08-29
• Study First Submitted QC: 2006-08-29
• Study First Posted: 2006-08-31
• Study Start: 2006-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2009-09-09
• Results First Submitted QC: 2009-09-09
• Status Verified: 2009-10
• Results First Posted: 2009-10-12
• Last Update Submitted: 2009-10-15
• Last Update Posted: 2009-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pemetrexed - Before Protocol Amendment	Pemetrexed - Before Protocol Amendment	-
Pemetrexed - After Protocol Amendment	Pemetrexed - After Protocol Amendment	-

Primary Outcome Measures

Name	Time	Method
Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3	pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)	dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).
Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3	pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)	dCK (see Outcome #1)and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).

Secondary Outcome Measures

Name	Time	Method
Best Objective Tumor Response	baseline to measured response (every 14 days for 6 cycles)	Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

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.; 🇮🇹 Milano, Italy