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

Lilly

Status and phase

Completed

Phase 2

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: Pemetrexed - Before Protocol Amendment

Drug: Pemetrexed - After Protocol Amendment

Study type

Interventional

Funder types

Industry

Identifiers

NCT00370292

10940

H3E-IT-S105

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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