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Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia (IP001)

CBDCA plus PTX for NSCLC (squamous) with IP (IP001)

35

Median age (range): 73yo(66-80) Male/Female : 31/4 PS 0/1/2/3: 11/24/0/0 Stage IIIA/ IIIB/IV/Recurrence: 7/8/15/5 EGFR mutation exon19del/L858R/unknown/-:0/0/0/24/11 Squamous cell carcinoma 35 UIP/CPFE/other:11/7/17

The study was terminated before the completion of the initial targeted sample size (40) because of poor accrual. Received treatment according to the protocol:36

Serious adverse events: Pneumonitis (8.6%), Myocardial infarction (2.9%) Grade3 or more:leukocytopenia (25.7%), neutropenia (42.9%), anemia (22.9%), thrombocytopenia (2.9%), increased AST (2.9%), increased ALT (2.9%), hyponatremia (8.6%), hypokalemia (2.9%), decreased PS (11.4%), fatigue (2.9%), constipation (5.7 %), infection (11.4%), dyspnea (5.7%), hypertension (17.1%), hemorrhoids (2.9%), duodenal bleeding (2.9%), febrile neutropenia (5.7%) Adverse events were considered to be within the expected or not protocol related.

Primary endpoint Response rate:45.7% Secondary endpoint 1)Overall survival: 9.99 month 2)Progression free survival:5.75 month 3)Time to treatment failure: 5.06 month 4) Adverse events: Pneumonitis 8.6% The response rate achieved the predetermined level. Secondary endpoints were also comparable to those previously reported.

Patients who had advanced squamous lung cancer complicated by IIP received CBDCA (AUC 5) on day 1 and paclitaxel (70 mg/m2) on days 1, 8, and 15 every 4 weeks. The response rate was 45.7% and the acute exacerbation rate of IIP was 8.6%. This regimen had an acceptable acute exacerbation rate with a reasonable response rate, suggesting that it is a candidate treatment for this population.

Oct. 29, 2021

No

No Plan

https://jrct.mhlw.go.jp/latest-detail/jRCTs051180149

Katakami Nobuyuki

Takarazuka City Hospital

5-1-4 Kohama, Takarazuka, Hyogo

nkatakami1954@gmail.com

Suzuki Hidekazu

Osaka Habikino Medical Center

3-7-1 Habikino, Habikino-shi, Osaka

+81-72-957-2121

suzukih@ra.opho.jp

Complete

Dec. 17, 2012

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

1) Squamous cell lung cancer
2) Age over twenty
3) Idiopathic interstitial pneumonia
4) Measurable lesion
5) ECOG performance status 0 or 1
6) Adequate organ function
WBC>=3000/mm3 and neutrophil count >=2000/mm3
Hgb>=10.0 g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<100 IU/L, ALT=<100 IU/L, CRN=<1.5mg/dL
7) PaO2>=60.0 torr or SpO2>=92.0 %( room air)
8) No symptoms from brain metastasis
9) Life expectancy > 3 months
10) Written informed consent

1) Secondly interstitial pneumonia.
2) History of acute exacerbation of interstitial pneumonia within 3 months.
3) Subacute progression of interstitial pneumonia within 3 months.
4) Using prednisolone or immune-suppressive agent.
5) Need to home oxygen therapy.
6) Past history of severe drug allergy.
7) Active infectious disease.
8) Severe complications
9) Symptomatic brain metastasis.
10) Uncontrollable effusion.
11) Active combined malignancy
12) Any ineligible case judged by physician.

Both

Squamous cell lung cancer

Carboplatin (AUC=5) given on day1 and paclitaxel (70mg/m2) given on days 1,8,15 every 4weeks until disease progression or unmanageable toxicity.

Lung cancer

Response rate

overall survival, progression free survival, time to treatment failure, adverse event

+81-744-29-8835

Mar. 08, 2019

none