UMIN-CTR Clinical Trial

Public title

Phase I/II trial of Carboplatin plus Pemetrexed in elderly patients with advanced non squamous non small cell lung cancer

Acronym

Phase I/II trial of Carboplatin plus Pemetrexed in elderly patients with advanced non squamous non small cell lung cancer

Scientific Title

Phase I/II trial of Carboplatin plus Pemetrexed in elderly patients with advanced non squamous non small cell lung cancer

Scientific Title:Acronym

Phase I/II trial of Carboplatin plus Pemetrexed in elderly patients with advanced non squamous non small cell lung cancer

Region

Japan

Condition

Clinical stage IV non squamous non small cell lung cancer chemotherapy naive patients over 70years old

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

Phase I trial Decide MTD and RD about the Carboplatin plus Pemetrexed to elderly non small non squamous cell lung cancer patients
Phase II trial Study efficacy and safety about the Carboplatin plus Pemetrexed to elderly non small non squamous cell lung cancer patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

Response rate

Key secondary outcomes

1 year survival rate, Progression free survival, Safety, QOL

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

We register patients in this trial from May 2010 to April 2012 and we will follow them another two years. We administer Carboplatin AUC4 plus Pemetrexed 500mg/m2 every 3 weeks and determine the RD after we assess the DLT in phase I trial. In phase II trial, we administer Carboplatin plus Pemetrexed from 2 to 6 courses according to the RD. We expect 55 patients to entry this phase II trial.

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

Diagnosis of non small cell lung cancer and non squamous cell lung cancer confirmed either histologically or cytologically
Recurrence after operation or clinical stage IV
No prior chemotherapy
Elderly patients over 70 years old
ECOG Performance status 0-1
Adequate bone marrow reserve and organ function
A measurable lesion according to the Response Evaluation Criteria in Solid Tumors
A projected life expectancy of at least 3 months
Written informed consent

Key exclusion criteria

Squamous cell carcinoma
Radiation therapy to primary cancer
SVC syndrome
Severe drug allergy
Severe pleural effusion or uncontrollable pleural effusion
Severe ascites or pericardiac effusion
Active infection
Symptomatic brain metastasis
Active concomitant malignancy
Active mental illness

Target sample size

67

Name of lead principal investigator

1st name
Middle name
Last name	Jiichiro Sasaki

Organization

Kumamoto university hospital

Division name

Respiratory medicine

Zip code

Address

1-1-1, Honjyo, Kumamoto city, Kumamoto prefecture, Japan

TEL

0963735012

Email

saji@gpo.kunanoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shinya Sakata

Organization

Kumamoto university hospital

Division name

Respiratory medicine

Zip code

Address

1-1-1, Honjyo, Kumamoto city, Kumamoto prefecture, Japan

TEL

0963735012

Homepage URL

Email

sakata-1027@hotmail.co.jp

Institute

Kumamoto university hospital

Institute

Department

Personal name

Organization

none

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

2010

Year

11

Month

27

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.karger.com/Article/Abstract/369255

Number of participants that the trial has enrolled

Results

Oncology. 2015;88(4):201-7. doi: 10.1159/000369255. Epub 2014 Dec 6.

Results
Grade 3 infection as a dose-limiting toxicity was observed at a carboplatin dose of AUC 6. We therefore determined a carboplatin dose of AUC 5 and a pemetrexed dose of 500 mg/m2 as the recommended doses from this study. The pharmacokinetic study showed a significant inverse correlation between the AUC of pemetrexed and the creatinine clearance.

Conclusions
For elderly chemotherapy-naive patients with advanced nonsquamous NSCLC, the combination of carboplatin AUC 5 plus pemetrexed 500 mg/m2 is recommended as a promising regimen, however, a reduction of the pemetrexed dose may be required for patients with renal dysfunction because of the high risk of hematotoxicities.

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

Completed

Date of protocol fixation

2010

Year

04

Month

26

Day

Date of IRB

Anticipated trial start date

2010

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

11

Month

27

Day

Last modified on

2016

Year

05

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005523