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Phase I / II Study of Alternating Chemotherapy with Cisplatin plus Nogitecan plus Paclitaxel (PlaTT) and Cisplatin plus Amrubicin plus Paclitaxel (PAT) for Advanced Lung Cancer Patients

Phase I / II Study of Alternating Chemotherapy with Cisplatin plus Nogitecan plus Paclitaxel (PlaTT) and Cisplatin plus Amrubicin plus Paclitaxel (PAT) for Advanced Lung Cancer Patients - Phase I / II Study of Alternating Chemotherapy for Advanced Lung Cancer Patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012270
Enrollment
18
Registered
2013-11-12
Start date
2010-10-30
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

Advanced Lung Cancer

Interventions

Dose of each agent was escalated according to the schedule below. Combination A Day 1 2 3 4 5 CDDP x TPT x x x x PTX x Lenograstim x Combination B Day 1 2 3 4 5 CDDP x AMR x x

Sponsors

Niigata Lung Cancer Treatment Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) StageIIIB/IV lung cancer proven by histology and/or cytology 2) ineligible for curative RT 3) No prior chemotherapy 4) Age 20<= <70 years PS 0-2 5) At least one or more measurable lesion by RECIST 6) Adequate organ function 7) Life expectancy more than three months. 8) Written Informed Consent

Exclusion criteria

Exclusion criteria: Patients were excluded if they had any active concomitant malignancies, symptomatic brain metastases, past history of severe allergic reactions to drugs, interstitial pneumonia identified by chest X-ray, superior vena cava syndrome, or other serious complications, such as uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure, uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural effusion or ascites.

Design outcomes

Primary

MeasureTime frame
1)DLT 2)MTD,RD

Secondary

MeasureTime frame
1)toxicity 2)tumor response

Countries

Japan

Contacts

Public ContactSatoshi Watanabe

Niigata University Medical and Dental Hospital Department of Respiratory Medicine and Infectious Diseases

satoshi7@med.niigata-u.ac.jp025-368-9325

Outcome results

None listed

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