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A combination phase I/II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer

A combination phase I/II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer - A combination phase I/II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000072
Enrollment
25
Registered
2005-08-22
Start date
2005-06-01
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

previously untreated elderly non-small cell lung cancer

Interventions

The treatment schedule included carboplatin, diluted with 500 ml of normal saline, given intravenously over 90 minutes on day 1, and gemcitabine with 100 ml of normal saline, given intravenously over

Sponsors

West Japan Oncology Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with histologic or cytologic confirmation of locally advanced or metastatic NSCLC who received either no prior chemotherapy were eligible. The eligibility criteria were as follows; (1) measurable lesions; (2) age ≥ 70; (3) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; (4) adequate organ function

Exclusion criteria

Exclusion criteria: The exclusion criteria consisted of pulmonary fibrosis or interstitial pneumonitis with symptoms or apparent abnormalities on chest X-ray, massive pleural effusion or ascites, acute inflammation, symptomatic brain metastases, active concurrent malignancies, severe drug allergies, severe heart disease, cerebrovascular disease, uncontrollable diabetes mellitus, severe infection.

Design outcomes

Primary

MeasureTime frame
to establish MTD and to determine the RD

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results

None listed

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