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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer
Both
Non Small Cell Lung Cancer
Trial Information
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
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
Outcome Time Frame:
pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)
Safety Issue:
No
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
Italy: Ministry of Health
Study ID:
10940
NCT ID:
NCT00370292
Start Date:
September 2006
Completion Date:
September 2008
Related Keywords:
- Non Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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