UMIN-CTR Clinical Trial

Public title

Phase II study for efficacy and safety of
nab-paclitaxel and carboplatin combination chemotherapy for Previously untreated advanced non-small cell lung cancer

Acronym

Phase II study of nab-PTX/CBDCA for elderly advanced NSCLC

Scientific Title

Phase II study for efficacy and safety of
nab-paclitaxel and carboplatin combination chemotherapy for Previously untreated advanced non-small cell lung cancer

Scientific Title:Acronym

Phase II study of nab-PTX/CBDCA for elderly advanced NSCLC

Region

Japan

Condition

non-small cell lung cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate for efficacy and toxicities of nab-paclitaxel and carboplatin combination chemotherapy for elderly (more than 70 years-old) untreated advanced non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

response rate

Key secondary outcomes

progression-free survival, overall survival, toxicities, number of cycles

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

carboplatin at the dose of area under curve 5 (day 1) and nab-paclitaxel at the dose of 100mg/m^2 (day 1, 8, 16) every 3 weeks, upto 6 cycles

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

Age-lower limit

70

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Definitively diagnosed with having previously untreated advanced non-small cell lung cancer by the specimens histologically or cytologically.
2) Age of more than 70 years-old
3) With adequate organ function of bone marrow reserve, liver, and kidney.
(1) PS 0-1
(2) neutrophil count => 1,500/mm^3
(3) platelet => 100,000/mm^3
(4) hemoglobin => 9.0g/dL
(5) AST/ALT < 2.5 times less than ULN
(6) T.Bil <= 1.5mg/dL
(7) serum creatinine <= 1.5mg/dL
(8) ECG: without clinically problematic abnorbomalities
(9) Peripheral neuropathy <= Grade 1
(10) SpO2 (room air) more than 92%
4) With the status of below previous treatment at the time of beginning of chemotherapy.
(1) Radiotherapy: irradiated extrathoracic lesion: more than two weeks from the date of last irradiation
(2) Surgical procedure, including pleurodesis or pleural drainage
* more than 8 weeks with lobectomy
* more than 4 weeks without lobectomy, including exploratory thoracotomy
* more than 2 weeks after completing procedure (pleurodesis or pleural drainage)
5) With expected prognosis more than 12 weeks
6) With written informed consent

Key exclusion criteria

1) The age of less than 70 years-old
2) Previously treated with chemotherapy
3) With uncontrolled brain metastasis
4) With clinically active infection
5) With severe complication (cardiac diseases, interstitial pneumonia, uncontrolled hypertension or diabetes)
6) With uncontrolled pleural effusion
7) With active other organ cancer
8) With the history of severe drug allergy
9) With the history of hypersensivity for paclitaxel, albumin-containing agents
10) With the history of hypersensitivity for platinum agents
11) With uncontrolled digestive ulcer
12) Any patients judged by the investigator to be unfit to participate in the study

Target sample size

38

Name of lead principal investigator

1st name
Middle name
Last name	Hosomi, Yukio

Organization

Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital

Division name

Department of Thoracic Oncology and Respiratory Medicine

Zip code

Address

3-18-22, Honkomagome, Bunkyo Tokyo

TEL

03-3823-2101

Email

yhosomi@cick.jp

Name of contact person

1st name
Middle name
Last name	Okuma, Yusuke

Organization

Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital

Division name

Department of Thoracic Oncology and Respiratory Medicine

Zip code

Address

3-18-22, Honkomagome, Bunkyo Tokyo

TEL

03-3823-2101

Homepage URL

Email

y-okuma@cick.jp

Institute

Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital

Institute

Department

Personal name

Organization

Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

05

Month

16

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://link.springer.com/article/10.1007%2Fs00280-016-3092-9

Number of participants that the trial has enrolled

Results

RESULTS: The study was interrupted early because of two treatment-related deaths and 1 life-threatening severe adverse event; therefore, only 10 patients (median age, 77 years; range 71-82 years) were enrolled. The primary end point of the objective response was 50 % for the 10 patients analyzed. Progression-free survival was 4.48 months [95 % confidence interval (CI) 0.36-6.44], and overall survival was 7.89 months (95 % CI 0.36-26.88). Common treatment-related adverse events higher than grade 2 included decreased neutrophil counts, anemia, decreased albumin, anorexia, and peripheral neuropathy. Regarding severe adverse events, two patients had febrile neutropenia and lung infection. Two patients died, and one patient had febrile neutropenia with intubation during the first cycle. The Data and Safety Monitoring Committee therefore recommended interruption of patient enrollment.
CONCLUSION: Nab-paclitaxel plus carboplatin, without dose reduction, is indicated to be toxic and intolerable as first-line chemotherapy in elderly Japanese patients with advanced NSCLC. Care must be taken when extrapolating the results of a clinical trial into clinical practice, particularly when the resulting subgroup analysis is of elderly patients because this patient group is composed of a heterogeneous population.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2013

Year

05

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

05

Month

01

Day

Last follow-up date

2016

Year

02

Month

29

Day

Date of closure to data entry

2016

Year

02

Month

29

Day

Date trial data considered complete

2016

Year

02

Month

29

Day

Date analysis concluded

2016

Year

02

Month

29

Day

Other related information

A phase II study of nanoparticle albumin-bound paclitaxel plus carboplatin as the first-line therapy in elderly patients with previously untreated advanced non-small cell lung cancer. Cancer Chemother Pharmacol. 2016 Jun 23. DOI: 10.1007/s00280-016-3092-9

Registered date

2013

Year

05

Month

16

Day

Last modified on

2016

Year

07

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012540