Unique ID issued by UMIN | UMIN000014314 |
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Receipt number | R000016615 |
Scientific Title | A phase II study of maintenance bevacizumab plus docetaxel following induction chemotherapy with cisplatin, pemetrexed plus bevacizumab for advanced non-squamous non-small-cell lung cancer |
Date of disclosure of the study information | 2014/06/19 |
Last modified on | 2020/08/25 10:41:39 |
A phase II study of maintenance bevacizumab plus docetaxel following induction chemotherapy with cisplatin, pemetrexed plus bevacizumab for advanced non-squamous non-small-cell lung cancer
A phase II study of maintenance bevacizumab plus docetaxel for Non-Sq NSCLC(HSR1401)
A phase II study of maintenance bevacizumab plus docetaxel following induction chemotherapy with cisplatin, pemetrexed plus bevacizumab for advanced non-squamous non-small-cell lung cancer
A phase II study of maintenance bevacizumab plus docetaxel for Non-Sq NSCLC(HSR1401)
Japan |
Advanced non-squamous non-small cell lung cancer
Pneumology |
Malignancy
NO
The objective of this study is to evaluate the efficacy and safety of bevacizumab plus docetaxel as maintenance therapy in patients who did not have progressive disease after receiving treatment with cisplatin, pemetrexed plus bevacizumab in advanced non-squamous non-small-cell lung cancer
Safety,Efficacy
Phase II
Progression free survival
Response rate, disease control rate, overall survival, safety, QOL score(EQ-5D)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Patients were included in the run-in phase (four cycles of cisplatin, pemetrexed plus bevacizumab).After induction chemotherapy, patients who did not have progressive disease receive bevacizumab plus docetaxel
20 | years-old | <= |
75 | years-old | >= |
Male and Female
All participants must meet the following criterias
1: Pathologically proven Non-Sq NSCLC
2: Radiographically measurable lesion
3: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
4: Stage 3B/4 NSCLC or recurrence disease without prior adjuvant chemotherapy
5: Age more than 20 years and less than 75 years
6: Adequate organ function
Neutrophil count: more than 1,500/uL
Platelet count: more than 100,000/uL
Hemoglobin: more than 9.0 g/dL
Aspartate transaminase (AST), alanine transaminase(ALT): 2.5 times the upper limit of normal of the institutional reference range
Total bilirubin: less than 1.5mg/dL.
PaO2: more than 60 torr
Creatinine: less than 1.2mg/dL
7: Life expectancy of more than 12 weeks
8: Written informed consent
Exclusion criteria are as follows
1: Squamous cell carcinoma
2: Active interstitial pneumonia identified by chest X-ray
3: Current or previous histoty of hemoptysis (2.5ml) due to NSCLC
4: Uncontrolled massive pleural effusion or cardiac effusion
5: Superior vena cava syndrome
6: Uncontrolled brain metastases
7: Uncontrolled diabetes mellitus, hypertension, hepatic disorder, angina pectoris or previous myocardial infarction within the last 3 months
8: Severe infection
9: Pregnancy or lactation
10: Active concomitant malignancy
11: History of severe allergic reactions to drugs
12: Evidence of bleeding diathesis or hemoptysis
13: Current or previous history of cerebrovascular disease
14: Current or previous history of GI perforation
15: With great vessel invasion
16: Exposure of the tumor to the central airway
17: Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day or Clopidogrel over 75mg/day)
18: Patients with arterial thrombosis or venous thrombosis
19: Severe and unstable medical comorbidities
20: Judgment to attending physician
45
1st name | Takafumi |
Middle name | |
Last name | Suda |
Hamamatsu Univ. School of Medicine
Department of Internal medicine, second division
4313192
Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan
053-435-2263
may15@hama-med.ac.jp
1st name | Seiichiro |
Middle name | |
Last name | Suzuki |
Hamamatsu Univ. School of Medicine
Department of Internal medicine, second division
4313192
Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan
053-435-2263
seszuki@hama-med.ac.jp
Hamamatsu Univ. School of Medicine
none
Self funding
Hamamatsu Univ School of Medicine
1-20-1 Handayama, Hamamatsu
053-435-2111
rinri@hama-med.ac.jp
NO
2014 | Year | 06 | Month | 19 | Day |
https://link.springer.com/article/10.1007/s12032-018-1172-x#citeas
Published
https://link.springer.com/article/10.1007/s12032-018-1172-x#citeas
49
The median progression-free
survival from enrollment was 7.8 month
2020 | Year | 08 | Month | 25 | Day |
Chemotherapy-naive
non-squamous NSCLC patients
Patients who achieved disease control after induction therapy then received maintenance
therapy with docetaxel (50 mg/m2) and bevacizumab (15 mg/kg) until disease progression or unacceptable toxicity.
The most common toxicities of grade
3 or higher were neutropenia (68.4%), leukopenia (50.0%), febrile neutropenia (31.8%), and hypertension.
The primary endpoint was progression-free survival from enrollment.
Completed
2014 | Year | 05 | Month | 14 | Day |
2014 | Year | 05 | Month | 14 | Day |
2014 | Year | 06 | Month | 19 | Day |
2016 | Year | 07 | Month | 01 | Day |
2014 | Year | 06 | Month | 19 | Day |
2020 | Year | 08 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016615
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