Phase 2
Completed N=19
Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov NCT00370292 ↗Enrolled (actual)
19
Serious AEs
26.3%
Results posted
Oct 2009
Primary outcomePrimary: Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 — 0.92; 0.92; 0.92; 0.96 mRNA relative values (ratio with GAPDH) — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 |
0.92; 0.92; 0.92; 0.96; 0.95; 0.96 | <0.001 sig |
| PRIMARY Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 |
0.86; 0.86; 0.87; 0.88; 0.89; 0.90 | <0.001 sig |
| SECONDARY Best Objective Tumor Response |
1; 0; 2; 4; 3; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00370292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.