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A phase I study of bi-weekly carboplatin/paclitaxel chemotherapy in elderly advanced non-small cell lung cancer

A phase I study of bi-weekly carboplatin/paclitaxel chemotherapy in elderly advanced non-small cell lung cancer - A phase I study of bi-weekly carboplatin/paclitaxel chemotherapy in elderly advanced non-small cell lung cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005263
Enrollment
11
Registered
2011-03-17
Start date
2010-01-01
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

Eligibility criteria were histologically or cytologically confirmed NSCLC, no prior treatment, ECOG performance status (PS) 0-2 and age &gt
70 years. PTX (90 or 100 mg/m2) were administered in combination with a fixed dose of CBDCA (area under the concentration-time curve
AUC of 3) on day 1 and 15 (every two weeks).

Sponsors

Shimane University Faculty of Medicine, Division of Clinical Oncology and Respiratory Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histology/cytology-proven non-small cell lung cancer, age of 70 years or over 2)No prior chemotherapy or prior 1-regimen of EGFR TKI 3)ECOG performance status of 0-2 4)Adequate reserves for marrow, renal, hepatic, and pulmonary functions 5)Acquisition of written informed consent

Exclusion criteria

Exclusion criteria: 1)Previous 2-regimen chemotherapy or 1-regimen of EGFR-TKI 2)Concurrent chemoradiotherapy 3)Serious infections 4)Ssymptomatic brain metastasis 5)Massive pericardial, pleural effusion, or ascites 6)Serious clinical probrems 7)Previous drug allergy or alchol allergy 8)Hoped to be pregnant/ nursing 9)Those judged to be not suitable by the attending physician

Design outcomes

Primary

MeasureTime frame
Maximum Tolerated Dose of CBDCA+PTX bi-weekly therapy

Secondary

MeasureTime frame
Anti tumor efficacy, Quality of life

Countries

Japan

Outcome results

None listed

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