Unique ID issued by UMIN | UMIN000002735 |
---|---|
Receipt number | R000003328 |
Scientific Title | A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients |
Date of disclosure of the study information | 2009/11/11 |
Last modified on | 2014/04/01 14:09:57 |
A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients
A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients
A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients
A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients
Japan |
Non-Small Cell Lung Cancer
Pneumology |
Malignancy
NO
Objective of the study is to investigate efficacy and safety of Erlotinib for previously treated non-small cell lung cancer patients.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
rseponse rate
disease control rate, progression free survival, overall survival, evaluation of safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
erlotinib single chemotherapy
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically or cytologically proven stage IIIb or IV non-small cell lung cancer.
2) Patients who have previously treated with one or two chemotherapy.
3) No prior treatment with epidermal growth factor tyrosine kinase inhibitor.
4) Patients who has at least one or more measurable lesion(s) by RECIST.
5) Performance status (ECOG) 0-2
6) Patients who can be hospitalized for at least two weeks after beginning of the treatment or under similar management.
7) Patients aged 20 years or older.
8) Sufficient function of main organ and bone marrow filled the following criteria:
Leukocyte counts, 3,000/mm3 or over -12,000/mm or less.
Neutrophil counts, 1,500/mm3 or over.
Platelets, 100,000/mm3 or over.
AST and ALT, x 2 of upper limit of normal (ULN) or less.
Total bilirubin, 1.5mg/dl or less.
Serum creatinin, x 1.5 of ULN or less.
SpO2 90% or above.
9) Patients who are considered to survive for more than 3 months.
10) interval:
(1) chemotherapy, more than 3 weeks after the last chemotherapy.
(2) Radiation, more than 12 weeks after the thoracic irradiation or more than 2 weeks after the last irradiation to other organs.
(3) Operation, more than 3 weeks after the last operation (including pleurodesis)
11) Patients providing written informed consent
1) Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis,or drug-induced pneumonitis
2) Patients with massive pleural or pericardial effusion,or ascites
3) Patients with active severe infections
4) Cases with past history of administration of HER related agents
5) Impossible cases with oral administration
6) Patients with active opthalmological disease
7) Pregnancy or lactation
8) Patients with symptomatic brain metastasis
9) Patients with active concomitant malignancy
10) Patients with uncontrollabe diabetes mellitus
11) Patients with uncontrollable complications
12) Inappropriate patients for this study judged by the physicians
38
1st name | |
Middle name | |
Last name | Akihito Yokoyama |
Kochi University, School of Medicine
Department of Hematology and Respiratory Medicine
Kohasu, Okocho, Nankoku city, Kochi, 783-8505, Japan
088-880-2345
im25@kochi-u.ac.jp
1st name | |
Middle name | |
Last name | Tetsuya Kubota |
Kochi University, School of Medicine
Department of Hematology and Respiratory Medicine
Kohasu, Okocho, Nankoku city, Kochi, 783-8505, Japan
088-880-2345
im25@kochi-u.ac.jp
Kochi University, School of Medicine, Department of Hematology and Resporatory Medicine
None
Self funding
NO
高知大学医学部付属病院(高知県)、高知医療センター(高知県)、国立病院機構高知病院(高知県)、高知赤十字病院(高知県)
2009 | Year | 11 | Month | 11 | Day |
Published
http://file.scirp.org/Html/2-2560032_42972.htm
9th JSMO annual meeting 2011
[Purpose] To evaluate the efficacy and safety of erlotinib in patients with previously treated non-small cell lung cancer (NSCLC), a phase II trial was studied in Kochi prefecture.[Patients and methods] Patients with stage IIIB/IV NSCLC and performance status 2 or lower, previously treated with 1 or 2 non- EGFR-TKI regimens were eligible. The enrollment has started since august 2009. Patients received Erlotinib (150mg/day) until disease progression or intolerable toxicity. Primary end point was the response rate (RR). In addition, disease control rate (DCR), progression free survival (PFS), and safety were evaluated.[Results] Thirty eight patients were enrolled, and 32 patients were evaluated. Median age was 69 years (range, 57 years to 80 years). Characteristics of patients were as follows: men/women, 21/11; PS0/1/2, 11/16/5; adenocarcinoma/ non-adenocarcinoma, 23/9. The objective RR and DCR were 31% and 65%, respectively. Twenty one patients could be evaluated for EGFR status (9 mutated/ 11 wild type). The RR of EGFR mutated patients was 67%, while wild type 17%. PFS of 24 cases were evaluated as 117 days. Major adverse events were tolerable skin toxicities, diarrhea, and stomatitis.[Conclusion] Erlotinib was efficacious in patients with previously treated NSCLC. Efficacy and safety were similar to previous reports.
Completed
2009 | Year | 06 | Month | 08 | Day |
2009 | Year | 07 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2013 | Year | 03 | Month | 31 | Day |
Advances in Lung Cancer
Vol.3 No.1(2014), 10-20.
DOI:10.4236/alc.2014.31002
2009 | Year | 11 | Month | 09 | Day |
2014 | Year | 04 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003328