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
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 |
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.
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
Italy,
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 |
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