A phase II study of pemetrexed plus carboplatin followed by pemetrexed maintenance therapy in chemotherapy-naive elderly patients with non-squamous non-small cell lung cancer

A phase II study of pemetrexed plus carboplatin followed by pemetrexed maintenance therapy in chemotherapy-naive elderly patients with non-squamous non-small cell lung cancer - A phase II study of pemetrexed plus carboplatin followed by pemetrexed maintenance therapy in chemotherapy-naive elderly patients with non-squamous non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000005221

Enrollment

Registered

2011-03-09

Start date

2011-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-squamous non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed non-squamous non-small cell lung cancer. (Non-Squamous NSCLC). 2.Stage III/IV unresectable or unsuitable for radical irradiation or postoperative recurrent Non-Squamous NSCLC. 3.No prior chemotherapy or post-operative recurrent disease without adjuvant chemotherapy or with at least six months interval from the last dosage of adjuvant chemotherapy. 4.Measurable tumor sites 5.ECOG-PS of 0 or 1. 6.>=70years-old,<85years-old 7.It is acceptable incorporated if it is determined that bone metastases is stable. 8.Life expectancy more than 3 months. 9.Adequate organ function. WBC count:>=4,000/mm3 neutrophil count:>=2,000/mm3 Platelet count:>=100,000/mm3 Hemoglobin:>=9.0g/dl AST,ALT<=100IU/l Total bilirubin:<=2.0mg/dl creatinine:<=1.2mg/dl PaO2 or SpO2:>=60torr or >=90% 10.Written informed consent from the patients.

Exclusion criteria

Exclusion criteria: 1.Interstitial pneumonia or pulmonary fibrosis detectable on CT scan. 2.Patients with active co-morbidities including severe conditions. *uncontrollable angina pectoris, myocardial infarction within 3 months, severe heart disease. *uncontrollable diabetes, hypertension. *severe infection *paresis of intestine, illeus *Patients whose participation in the trial is judged to be inappropriate by the attending doctor. 3.Patients with massive pleural and cardiac effusion and ascites that need to be immediately treated. 4.Brain metastases with neurological symptoms. 5.SVC syndrome. 6.Active double cancer. 7.Pregnancy, breast feeding and suspected pregnancy. 8.History of grave drug allergic reaction. 9.Psychiatric disorder. 10.Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor.

Design outcomes

Primary

Measure	Time frame
1 year survival	—

Secondary

Measure	Time frame
Response rate Disease control rate Progression free Survival Overall survival Adverse events QOL(EQ-5D,VAS scale)	—

Countries

Japan

Contacts

Public ContactMasaharu Shinkai

Yokohama City University Hospital Respiratory medicine

shinkai@yokohama-cu.ac.jp045-787-2800

Outcome results