Phase II study of oral vitamin B12 (cobalamin) supplementation with pemetrexed therapy in previously treated patients with advanced non-small cell lung cancer

Phase 2

• Conditions: on-small cell lung cancer

• Registration Number: JPRN-UMIN000003180
• Lead Sponsor: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

1) Extensive interstitial pneumonitis 2) Severe complications 3) Active infection 4) Active double cancer 5) Need for continuous administration of systemic corticosteroids 6) Need for continuous administration of systemic vitamin B12 7) Symptomatic brain metastases 8) Massive pleural effusion or ascites 9) History of irradiation to pelvic bone 10) Allergy to treatment drugs 11) Pregnant or breast-feeding 12) Grade 3/4 peripheral sensory neuropathy 13) Unable to take drugs orally 14) History of gastric or small intestinal resection 15) Other conditions inadequate for this research

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of grade 3/4/5 neutropenia

Secondary Outcome Measures

Name	Time	Method
The incidence of grade 3/4/5 toxicities and plasma homocysteine levels