Non-small cell lung cancer
Conditions
Interventions
Patients receive vitamin B12 (2mg for 7days, then 0.5mg) orally daily beginning 1 week before first dose of pemetrexed and throughout the study.
Sponsors
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven non-squamous non-small cell lung cancer 2) Stage IIIorIV disease or postoperative recurrence 3) Experience of at least 1 regimen of cytotoxic chemotherapy 4) No experience of pemetrexed therapy 5) ECOG performance status 0-2 6) Interval of at least 3 weeks from last treatment 7) Adequate bone marrow, renal, hepatic and cardiopulmonary function 8) Life expectancy of at least 12 weeks 9) Written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 3/4/5 neutropenia | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of grade 3/4/5 toxicities and plasma homocysteine levels | — |
Countries
Japan
Contacts
Public ContactYusuke Takagi
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital Department of Thoracic Oncology
Outcome results
None listed