Phase 4
Completed N=33
Chemotherapy for Patients With Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00380718 ↗Enrolled (actual)
33
Serious AEs
39.4%
Results posted
Oct 2009
Primary outcomePrimary: Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR]) — 0.182 proportion of responders
Summary
The purpose of this study is to assess the efficacy and toxicity of pemetrexed dosing that is tailored to individual patient tolerance in patients with advanced non-small cell lung cancer (NSCLC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR]) |
0.182 | — |
| SECONDARY Proportion of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate [DCR]) |
0.545 | — |
| SECONDARY Overall Survival |
20.2 | — |
| SECONDARY Progression-Free Survival (PFS) |
6.9 | — |
| SECONDARY Duration of Response |
6.6 | — |
| SECONDARY Time to Treatment Failure |
2.9 | — |
| SECONDARY Time to Tumor Progression |
6.9 | — |
Eligibility Criteria
Inclusion Criteria
- Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV)
- Patients' NSCLC must have progressed following one chemotherapy regimen for palliative therapy with or without subsequent targeted biological therapy
- Disease status must be that of measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Exclusion Criteria
- Concurrent administration of any other tumor therapy
- Pregnancy or breast feeding
- Serious concomitant disorders
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
Data sourced from ClinicalTrials.gov (NCT00380718). 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.