Phase 2
Completed N=111
A Study for Patients With Non-Squamous Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00609518 ↗Enrolled (actual)
111
Serious AEs
32.4%
Results posted
Nov 2010
Primary outcomePrimary: Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity — 15; 18 participants
Summary
Chemotherapy for patients with non-squamous non-small cell lung cancer. Patients are given folic acid, vitamin B12 and steroids, both before and during treatment, to reduce the side effects associated with pemetrexed. The aim is whether it is possible to simplify the folic acid and steroid schedule without increasing toxicity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity |
15; 18 | — |
| SECONDARY Proportion of Participants With Best Overall Tumor Response (Response Rate) |
0.118; 0.064 | 0.4902 |
| SECONDARY Overall Survival |
8.2; 9.2 | 0.6791 |
| SECONDARY Progression-free Survival (PFS) |
3.7; 3.8 | 0.5870 |
Eligibility Criteria
Inclusion Criteria
- Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC) with locally advanced or metastatic disease (Stage IIIA, IIIB or IV)that is of non-squamous histology
- Patients must have failed only one prior chemotherapy regime and must be considered eligible for further chemotherapy following progression of their disease.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate organ function
Exclusion Criteria
- Concurrent administration of any other anti-tumor therapy
- Other co-existing malignancies
- Pregnancy or breast feeding
- Serious concomitant disorders
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
Data sourced from ClinicalTrials.gov (NCT00609518). 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.