A Study for Patients With Non-Squamous Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Folic Acid; Hydroxocobalamin; Pemetrexed; Vitamin B 12; Vitamin B Complex; Vitamins

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