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

Non Small Cell Lung Cancer Clinical Trial

Official title:

Pemetrexed Monochemotherapy in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer. A Pilot Study to Define the Best Dosing Schedule for a Planned Phase II Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370292
• Other study ID #: 10940
• Secondary ID: H3E-IT-S105
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2006
• Last updated: October 15, 2009
• Start date: September 2006
• Est. completion date: September 2008

Study information

• Verified date: October 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Histologically or cytologically proven IIIB and IV NSCLC.

• No symptomatic uncontrolled brain metastasis

• Not suitable for platinum containing regimens if chemo-naive

• Performance status less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale.

• Creatinine Clearance (CrCl) greater than or equal to 45 milliliters per min (mL/min)

Exclusion Criteria

• Prior radiation to greater than 25% of bone marrow

• Inability to interrupt Aspirin at doses of greater than 1.3 grams/day or non-steroidal anti-inflammatory agents for a 5-day period.

• Presence of clinically relevant third-space fluid collections not controllable.

• Significant cardiac disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Pemetrexed - Before Protocol Amendment
500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue
• Pemetrexed - After Protocol Amendment
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	Best Objective Tumor Response		baseline to measured response (every 14 days for 6 cycles)	No

External Links

•   Lilly Clinical Trial Registry