Skip to content

Phase I study of Pemetrexed/CDGP for advanced and relapsed NSCLC after thoracic surgery

Phase I study of Pemetrexed/CDGP for advanced and relapsed NSCLC after thoracic surgery - Phase I study of Pemetrexed/CDGP chemptherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002586
Enrollment
24
Registered
2009-11-01
Start date
2009-11-01
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

chemotherapy

Sponsors

Shinshu University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with histologically or cytologically confirmed NSCLC, who had not previously received any chemotherapy or radiotherapy, and relased after thoracic surgery. Other criteria included: 1) age >20 and <75 years; 2) Eastern Clinical Oncology Group (ECOG) performance status 0–1; 3) unresectable stage IIIb or IV disease; 4) adequate bone marrow function (neutrophil count >2 x 103/µl, hemoglobin 10 g/dl, platelet count > 10 x 10 4/µl), normal hepatic function (total bilirubin level < 1.5 mg/dl and AST < twice the upper normal limit), and renal function (serum creatinine <1.2 mg/dl, creatinine clearance > 60 ml/min). PO2 >60 torr.

Exclusion criteria

Exclusion criteria: 1) interstitial pneumonia on chest XP, 2) pleural or pericardial effusion that required drainage, 3)neuropathy grade over 2, 4) systemic edema grade over 2, 5) severe heart disease, hypertension, DM, 6) active infection 7) active brain metastasis, or 8) pregnancy. 9) double cancers, 10) past history of hypersensitivity to drugs,

Design outcomes

Primary

MeasureTime frame
To determine the recommended dose of ALIMTA/CDGP combined chemotherapy

Countries

Japan

Outcome results

None listed

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