Phase I Study of Pemetrexed Combined with Carboplatin for Elderly Patients with Advanced Non-small Cell Lung Cancer

Phase I Study of Pemetrexed Combined with Carboplatin for Elderly Patients with Advanced Non-small Cell Lung Cancer - Phase I Study of PEM/CBDCA for elderly NSCLC

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003231

Enrollment

Registered

2010-02-22

Start date

2010-02-01

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-small-cell lung cancer

Interventions

Pemetrexed Carboplatin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven non-small-cell lung cancer. 2) Aged >= 75 years. 3) ECOG performance status: 0-1 4) Patient who has measurable lesion by RECIST. 5) No prior chemotherapy for NSCLC. Interval from previous treatment, of following, at enrollment; (a) Surgery: more than 4 weeks after surgery. (b) Radiation: more than 4 weeks after the thoracic irradiation or more than 2weeks after the last irradiation to the other organs. 6) No history of receiving chemotherapy against other concomitant malignancy. 7) Adequate organ functions; (a) WBC >= 4,000/mm3 and Netrophile >= 2,000/mm3 (b) Hb >= 9.0 g/dL (c) Plt >= 100,000/mm3 (d) T. Bil <= 1.5 g/dL (e) AST and ALT, <= 100 U/L (f) Serum creatinine <= 1.5 mg/dL and Ccr >= 45ml/min/body (g) PaO2 >= 70 torr (at room) 8) Written informed consent. 9) Life expectancy >= 3 months

Exclusion criteria

Exclusion criteria: 1) Patients with active concomitant malignancy. 2) Patients with massive pleural or pericardial effusion. 3) Patients with symptomatic brain metastasis. 4) Patients with diarrhea or ileus at enrollment. 5) Active lung disease such as interstitial pneumonia, idiopathic pulmonary fibrosis. 6) Patients with other clinically significant complications. (a) uncontrollable cardiovascular disease. (b) uncontrollable diabetes and hypertension. (c) Active severe infections. (d) History of active psychological disease. 7) Patients with steroid treatment. 8) Patients who had a history of severe drug allergy. 9) Inappropriate patients for this study judged by the physicians.

Design outcomes

Primary

Measure	Time frame
To estimate maximum tolerated dose and determine the recommended dose	—

Countries

Japan

Contacts

Public ContactHiroaki Takeoka, Kazuhiko Yamada

Kurume University School of Medicine Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine

kayamada@med.kurume-u.ac.jp0942-31-7560

Outcome results

None listed

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