UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000084
Receipt number R000000136
Scientific Title Second line chemotherapy consisting of weekly irinotecan and cisplatin for relapsed/first line resistant non-small cell lung carcinoma - phase II study
Date of disclosure of the study information 2005/09/01
Last modified on 2009/08/31 08:34:27

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Basic information

Public title

Second line chemotherapy consisting of weekly irinotecan and cisplatin for relapsed/first line resistant non-small cell lung carcinoma - phase II study

Acronym

Second line chemotherapy consisting of weekly irinotecan and cisplatin for relapsed/first line resistant non-small cell lung carcinoma - phase II study

Scientific Title

Second line chemotherapy consisting of weekly irinotecan and cisplatin for relapsed/first line resistant non-small cell lung carcinoma - phase II study

Scientific Title:Acronym

Second line chemotherapy consisting of weekly irinotecan and cisplatin for relapsed/first line resistant non-small cell lung carcinoma - phase II study

Region

Japan


Condition

Condition

Non-small-cell lung carcinoma

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate clinical relevance of weekly irinotecan and cisplatin for patients with relapsed and/or first line chemotherapy resistant non-small-cell lung carcinoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate (6 weeks interval for confirming SD)

Key secondary outcomes

Toxicity
Survival


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

Chemotherapy
CPT-11 (60 mg/m2, weekly)
CDDP (25 mg/mg2, weekly)
at leaset 6 courses

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

15 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Histologically/cytologically proven non-small-cell lung cancer
2) Prior chemotherapy of single regimen chemotherapy
3) Resistant to first line chemotherapy or relapsed after the chemotherapy
4) PS (ECOG); 0 - 2
5) Age ranging from 15 to 74
6) Preserved organ functions as
a) WBC >= 3,000/mm3, neutrophile >= 2,000/mm3, Hb >= 9.0 g/dl, Plt >= 100,000/mm3
b) T. Bil <= 1.5 mg/dl, AST/ALT < 2 x upper limit of the normal value
c) Creatinine <= 1.5 mg/dl, Creatinine crearance >= 40 ml/min
d) PaO2 >= 70 torr
7) Measurable lesions by RECIST
8) Life expectancy for more than 8 weeks
9) Written informed consent

Key exclusion criteria

1) Prior chemotherapy including irinotecan
2) Prior chemotherapy by 2 or more chemotherapeutic regimens
3) Prior resection
4) Requirement of thoracic irradiation
5) Any contraindication for irinotecan, such as interstitial pneumonitis
6) Pleural effusion/ascites requiring treatment
7) Pericardial effusion
8) Serious concomitant medical conditions, including uncontrolled diabetes mellitus, angina pectoris, myocardial infarction within 3 months, and others
9) Brain metastasis requiring treatment
10) Concomitant malignancy
11) History of serious drug allergy
12) Pregnancy, potential pregnancy, or breast feeding
13) Others

Target sample size

48


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takiguchi, Yuichi

Organization

Chiba University

Division name

Department of Respirology (B2)

Zip code


Address

1-8-1, Inohana, Chuo-Ku, Chiba, Japan

TEL

043-226-2577

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takiguchi, Yuichi

Organization

Chiba University

Division name

Department of Respirology (B2)

Zip code


Address

1-8-1, Inohana, Chuo-Ku, Chiba, Japan

TEL

043-226-2577

Homepage URL


Email

takiguchi@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba Lung Cancer Study Group

Institute

Department

Personal name



Funding Source

Organization

Chiba Lung Cancer Study Group

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2005 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Even with the standard first-line chemotherapy, advanced non-small cell lung cancer (NSCLC) recurs in most cases. The purpose of this study is to develop a new chemotherapeutic regimen for patients with NSCLC that has relapsed or was refractory to previous chemotherapy. Patients with proven NSCLC refractory or recurrent after previous single-regimen chemotherapy, PS of 0 to 2, age of 15 years or older, adequate organ functions and measurable lesions were treated with irinotecan at 60 mg/m2 and cisplatin at 25 mg/m2 with 1,000 ml hydration on day 1. This administration, considered as one cycle, was repeated every week without rest unless encountering defined skip and dose-reduction criteria. The treatment was administered for 6 cycles over a 49-day period, both median values, to 48 patients, with a response rate of 26%, progression free and median survival times of 3 and 11 months, respectively, and a 1-year survival rate of 46%. The most frequent grade 3 or 4 toxicities were neutropenia, anaemia and nausea, which were manageable. Subset analyses suggested that the response rate was independent of response to the first-line chemotherapy. In conclusion, second-line chemotherapy of weekly irinotecan and cisplatin with minimum hydration seemed effective, with tolerable toxicity, and is potentially useful irrespective of the outcome of previous chemotherapy.

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



Progress

Recruitment status

Completed

Date of protocol fixation

2001 Year 07 Month 17 Day

Date of IRB


Anticipated trial start date

2001 Year 10 Month 01 Day

Last follow-up date

2006 Year 12 Month 01 Day

Date of closure to data entry

2007 Year 01 Month 01 Day

Date trial data considered complete

2007 Year 01 Month 01 Day

Date analysis concluded

2007 Year 03 Month 01 Day


Other

Other related information

Takiguchi Y, Moriya T, Asaka-Amano Y, Kawashima T, Kurosu K, Tada Y, Nagao K, Kuriyama T. Phase II study of weekly irinotecan and cisplatin for refractory or recurrent non-small cell lung cancer. Lung Cancer 2007; 58: 253-259.


Management information

Registered date

2005 Year 08 Month 29 Day

Last modified on

2009 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000136


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name