Unique ID issued by UMIN | UMIN000015662 |
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Receipt number | R000018059 |
Scientific Title | Phase II Study of Carboplatin+nab-Paclitaxel for Non-small Cell Lung Cancer with Interstitial Pneumonitis |
Date of disclosure of the study information | 2014/11/12 |
Last modified on | 2022/05/03 23:52:50 |
Phase II Study of Carboplatin+nab-Paclitaxel for Non-small Cell Lung Cancer with Interstitial Pneumonitis
Phase II Study of Carboplatin+nab-Paclitaxel for Non-small Cell Lung Cancer with Interstitial Pneumonitis
Phase II Study of Carboplatin+nab-Paclitaxel for Non-small Cell Lung Cancer with Interstitial Pneumonitis
Phase II Study of Carboplatin+nab-Paclitaxel for Non-small Cell Lung Cancer with Interstitial Pneumonitis
Japan |
Advanced Non-small Cell Lung Cancer with Interstitial Pnumonitis
Pneumology |
Malignancy
NO
To assess the safety and efficacy of carboplatin plus nab-paclitaxel in patients with advanced non-small-cell lung cancer with interstitial pneumonitis.
Safety,Efficacy
Phase II
Treatment completion rate (>=4cycles)
Overrall response rate(ORR), Disease control rate(DCR), Progression free survival(PFS), Overall survival (OS), Safety (frequency of of acute exacerbation of interstitial pneumonitis, frequency of the other adverse effects)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Four to six cycles of Carboplatin day1(AUC5) plus Nab-Paclitaxel day1,8,15 (100mg/m2) every 4 weeks .
20 | years-old | <= |
80 | years-old | > |
Male and Female
1)Histologically or cytologically confirmed non-small cell lung cancer (if mixed type, judged by major histology)
2)Clinical stageIIIA, IIIB not amenable to curative treatment or stage IV, or post operative reccurence (TNM classification, 7th edition)
3) Eligible with or without EGFR mutation , Eligible with or without ALK translocation
4) Interstitial pneumonitis confirmed by high resolution chest CT (less than 2.5mm slice)
eligible pirfenidone or inhalation of NAC without the activity of interstitial pnumonitis
eligible secondary interstitial pnumonitis except IIP
fill at least 2 of the following radiological findings and eligible judged by central review; honeycoming, traction ectasia, ground-grass opacity, interlobular septal thickening
5) Patients aged 20-79
6) ECOG PS 0-1
7) Patients are excepted to live at least 12 weeks
8) Eligible with or without measurable lesions
9) No prior chemotherapy (eligible; In case of postoperative recurrence, 8 weeks or more than 8 weeks after operation. If performed adjuvant chemotherapy, equal or more than 6 months after the day of the final adjuvant chemotherapy)
10) Adequate organ function, evaluated within 14 days before enrollment
WBC >=3,000/mm3
Neu >=1,500/mm3
Plt >=100,000/mm3
Hb>=9.0g/dl
AST<=2.5XULN, /ALT<=2.5XULN
T.Bil<=1.5mg/dl
sCr<=1.5mg/dl
PaO2>= 70torr
11) less than Grade 2 peripheral neuropathy
12) Written informed consent from the patients
13) No prior radiation therapy for primary cancer (eligible palliative radiation therapy except primary lesion which has done more than 2 weeks before.
1) Active double cancer
2) Being suspected acute or sub-acute exacerbation of interstitial pneumonitis. Being experienced acute exacerbation of idiopathic interstitial pneumonia.
3) Receiving steroids or immunosuppressants within 3 month for interstitial pneumonia
4) Patiens has pleural effusion, pericardial effusion and ascites to need dranage
5) Serious complications as follows;
History of uncontrollable angina pectoris, acute myocardial infarction or heart faliure, etc within 6 months
History of cerebral infarction within 6 months
Uncontrollable diabetes mellitus, hypertension and diarrhea
Active infectious disease or suspected active infectious disease
Other Serious complications
(ileus, bleeding tendency , SVC syn. Varicella etc)
6) symptomatic brain metastasis
7) Pregnancy, breast feeding and suspected or wish of pregnancy. Men and women who declined contraception
8) Patients who have serious drug hypersensitivity reaction
9) Patients who have received a radiation therapy in chest
10) Having a schedule of operations
11) Patients whose participation in the trial is judged to be inappropriate because of psychiatric disease or psychiatric symptoms
12) Positive HBs antigen
13) Patients whose participation in the trial is judged to be inappropriate by the investigators
30
1st name | |
Middle name | |
Last name | Miyazaki Yasunari |
Tokyo Medical and Dental university
Department of Integrated Pulmonology
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
03-5803-5954
ninase@tmd.ac.jp
1st name | |
Middle name | |
Last name | Hiroyuki Sakashita |
Tokyo Medical and Dental university
Department of Integrated Pulmonology (Clinical Oncology)
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
03-5803-5954
hsakashita.pulm@tmd.ac.jp
Yushima Lung Cancer Oncology Group(YLOG)
Department of Integrated Pulmonology, Tokyo Medical and Dental university
Self funding
NO
2014 | Year | 11 | Month | 12 | Day |
https://onlinelibrary.wiley.com/doi/10.1111/1759-7714.14376
Published
https://onlinelibrary.wiley.com/doi/10.1111/1759-7714.14376
25
The 4-week modified regimen of carboplatin and nab-paclitaxel showed tolerable toxicity with favorable efficacy in NSCLC patients with ILD. This regimen may be an effective treatment option for patients in real clinical settings.
2022 | Year | 05 | Month | 03 | Day |
The median age was 71 years, and 23 patients were male. Fifteen patients had PS 0 (60%), and the rest were PS 1 (40%). Adenocarcinoma, Sq, and large cell carcinoma were observed in nine (36%), 11 (44%), and one (4%) patient, respectively, and the others were categorized as not otherwise specified. Nine patients (36%) were EGFR mutation negative, and the rest of patients were unknown. Seven patients (28%) were ALK rearrangement negative, and the rest of patients were unknown. Two patients (16%) were never smokers. Among the imaging findings for ILD on HRCT, honeycombing, traction bronchiectasis, interlobular septal thickening, and ground grass opacity were observed in 12 (48%), 23 (92%), 21 (84%), and 21 (84%) patients, respectively. Two patients were diagnosed with RA, manifesting as RA-related ILD at enrollment. Two other patients showed anticyclic citrullinated peptide (CCP) antibody positivity without symptoms of RA at the time of enrollment, but one of them was later diagnosed with RA and RA lung. The other patients were considered idiopathic. The positive incidence rate and median serum level of KL-6 were 84% and 747 U/ml, respectively.
Nineteen patients (76%) received four or more cycles of the protocol treatment.
The most common hematological grade 3 or 4 adverse event was neutropenia (48%), while febrile neutropenia was not observed. The most common nonhematological adverse events were fatigue (76%), followed by appetite loss (60%). Peripheral neuropathy was observed in 10 patients (40%) without grade 3 or 4 neuropathy. Three patients experienced 2 or more than grade 2 pneumonitis, and one patient met the acute exacerbation criteria.
Of the 25 patients enrolled in our study, one patient (4%) achieved CR, 10 patients (40%) showed PR, and 11 patients (44%) had SD. Only one patient showed progressive disease (PD), and two patients had a disease status that could not be evaluated. Thus, the ORR and DCR were 44% and 88% respectively. The unconfirmed ORR response rate was 64%. The median PFS and OS were 5.8 months and 15.8 months, respectively.
Completed
2014 | Year | 07 | Month | 20 | Day |
2014 | Year | 09 | Month | 26 | Day |
2014 | Year | 11 | Month | 12 | Day |
2021 | Year | 03 | Month | 31 | Day |
2014 | Year | 11 | Month | 11 | Day |
2022 | Year | 05 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018059
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