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An exploratory study to find predictive factors for adverse effects of pemetrexed in patients with lung cancer

An exploratory study to find predictive factors for adverse effects of pemetrexed in patients with lung cancer - Predictive factors for adverse effects of pemetrexed

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000009366
Enrollment
60
Registered
2012-11-20
Start date
2012-10-01
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 and non-small cell lung cancer, pleural mesothelioma

Interventions

None listed

Sponsors

National center for global health and medicine
Lead Sponsor
Department of Medical oncology, Funabashi Municipal Medical Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-squamous and non-small cell lung cancer and malignant pleural mesothelioma 2) Stage IIIB without any indication for radiotherapy or Stage IV or recurrent disease after surgery or radiotherapy 3) Treated with pemetrexed including regimen 4) ECOG PS 0-1 5) 20 years old or older 6) With or without measurable lesion 7) Adequate organ function evaluated within 14 days before enrollment 8) Life expectancy more than 12 weeks 9) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Treated with concurrent radiotherapy 2) Inappropriate for administration of pemetrexed a) a history of serious drug hypersensitivity b) severe myelosuppression, renal or hepatic dysfunction c) contraindicated for the use of pemetrexed d) severe comorbid disease e) administration of systemic antimicrobial agents f) continuous drainage for pleural effusion, ascites or cardiac effusion g) brain metastasis with any symptoms h) administration of systemic steroid i) pregnancy, lactation or intention to pregnancy j) judged to have difficulty in participation in this study because of psychosis or neurologic disease k) judged to be inadequate for this study by doctors

Design outcomes

Primary

MeasureTime frame
Adverse effects during 2 cycles of pemetrexed including chemotherapy

Secondary

MeasureTime frame
Response rate by RECIST criteria Progression free survival

Countries

Japan

Contacts

Public ContactYuichiro Takeda

National center for global health and medicine Department of Respiratory Medicine

ytakeda@hosp.ncgm.go.jp03-3202-7181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026