UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of weekly nab-paclitaxel in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy.
Title of the study (Brief title)	Phase II study of weekly nab-PTX in patients with NSCLC previously treated with platinum-based chemotherapy.
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of nab-paclitaxel monotherapy in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	Overall Survival Progression Free Survival Time to Treatment Failure Disease Control Rate Adverse Events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Nab-paclitaxel 100mg/m2 is administered by an infusion lasting 30 minutes on days 1, 8, 15 every 4weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically confirmed non-small cell lung cancer 2) Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence 3) Disease progression or recurrence after the last treatment for non-small cell lung cancer is confirmed by radiological image. The number of previous regimens must be 2 or less *Previous treatments should include at least one platinum-based regimen *Adjuvant chemotherapy is counted as one regimen if the disease recurred within a year after the completion of postoperative adjuvant chemotherapy, or within a year after surgery in patients given preoperative adjuvant chemotherapy * The following treatments are not counted as one regimen 1.Picibanil use for pleurosclerosis 2.Continuation maintenance therapy 3.EGFR-TKI and ALK inhibitor use for each driver mutation 4) At least one measurable lesion 5) Age of 20 years or older 6) ECOG Performance status of 0-2 7) Sufficient major organ function as bellow *Neutrophil count >= 1,500 /mm3 *Platelet count >= 100,000 /mm3 *Hemoglobin >= 9.0 g/dL *AST <= 100 IU/L *ALT <= 100 IU/L *total bilirubin <= 1.5 mg/dL *PaO2 >= 60 Torr or more (or SpO2 >= 94% or more) 8) Written informed consent
Key exclusion criteria	(1) Previous treatment with paclitaxel (2) Patients who remain influence of prior treatment which disturb protocol treatment (3) Symptomatic brain metastasis 4) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion 5) Active infection requiring administration of systemic treatment with antibiotics. e.g. Body temperature rose higher than 38 degree centigrade 6) Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis (except documented radiation pneumonitis) or pulmonary fibrosis, poorly-controlled diabetes, cardiac failure, renal failure, liver failure, active gastrointestinal ulceration, myocardial infarction within 6 months, and Grade 3 or higher angina 7) Patients with autoimmune disease requiring treatment with an immunosuppressive agent such as azathiopurine, chlorambucil, cyclophosphamide, ciclosporin, methotrexate, and steroids 8) Active double cancer (synchronous cancer, or metachronous cancer with less than 5 years of disease-free interval), except in situ cervical cancer cured by local treatment, gastric or colon cancer curatively resectable with endoscopy, and resectable non-melanoma skin cancer 9) Confirmed or possible pregnancy, lactation, willingness to become pregnant (for women), or willingness to have a child (for men) 10) Psychiatric disorder or symptom that makes participation of the patient difficult 11) Continuous administration of a steroid 12) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size	40

Research contact person
Name of lead principal investigator	Yuka Fujita
Organization	National Hospital Organization Asahikawa Medical center
Division name	Respiratory Medicine
Address	7 Hanasaki-cho Asahikawa Hokkaido 070-8644 Japan
TEL	0166-51-3161
Email	yuka@asahikawamc.hosp.go.jp

Public contact
Name of contact person	Yuka Fujita
Organization	National Hospital Organization Asahikawa Medical center
Division name	Respiratory Medicine
Address	7 Hanasaki-cho Asahikawa Hokkaido 070-8644 Japan
TEL	0166-51-3161
Homepage URL
Email	yuka@asahikawamc.hosp.go.jp

Sponsor
Institute	National Hospital Organization Asahikawa Medical center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	独立行政法人国立病院機構　旭川医療センター（北海道）

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 11 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 12 Month 13 Day
Anticipated trial start date	2014 Year 02 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 03 Month 11 Day
Last modified on	2016 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015272