UMIN-CTR Clinical Trial

Basic information
Public title	A combination phase II study of paclitaxel and gemcitabine for recurrent or relapsed non-small cell lung cancer previously treated with platinum or docetaxel-based regimen
Acronym	Phase II study of paclitaxel and gemcitabine for previously treated non-small cell lung cancer
Scientific Title	A combination phase II study of paclitaxel and gemcitabine for recurrent or relapsed non-small cell lung cancer previously treated with platinum or docetaxel-based regimen
Scientific Title:Acronym	Phase II study of paclitaxel and gemcitabine for previously treated non-small cell lung cancer
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of paclitaxel and gemcitabine for non-small cell lung cancer previously treated with platinum or docetaxel
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate (according to RECIST criteria)
Key secondary outcomes	Adverse events, Survival rate, Survival time, Time to progression, Completion of the treatment

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	The chemotherapy consisted of paclitaxel 150 mg/m2, iv, on day 1 ,and gemcitabine 1000 mg/m2, iv, on days 1 and 8. The treatment was repeated every 3 weeks.
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	Not applicable
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically confirmed non-small cell lung cancer. 2) Stage IV or IIIB unsuitable for thoracic radiation. 3) Measurable lesions. Measurable lesions should exist outside of the radiation field. 4) Non-small cell lung cancer with previous chemotherapy containing platinum or docetaxel. One or two previous regimens are allowed. 5) Age<75 6) ECOG PS 0-1 7) Adequate organ function WBC>4000/mm2; Hg>10.0g/dl; Platelet count>100,000/mm2; Total bilirubin<1.5mg/dl; AST & ALT <2x upper normal limit; Serum-creatinine65torr 8) Life expectancy of more than 3months. 9) No complication of serious heart and pulmonary diseases. 10) No active double cancer within 3 year. 11) Written informed consent.
Key exclusion criteria	1) Patients with lesions that can not judged for response by only chemotherapy. Patients previously treated with chemoradiotherapy are not allowed to be enrolled. 2) Active infectious disease and complications that affect the trial. 3) Apparent interstitial pneumonitis or fibrosis on chest X ray. 4) Symptomatic brain metastases. 5) Patients requiring pleural/ pericardial drainage. 6) Previous chemotherapy with gemcitabine or paclitaxel. 7) Allergy for a polyoxyethylene castor oil or a hardening castor oil component drug. 8) Woman who has a possibility of pregnancy. 9) Interval less than 30days from the last day of a previous treatment. 10) Other patients unsuitable for the study.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobuyuki Katakami
Organization	Kobe City General Hospital
Division name	Division of Respiratory Medicine
Zip code
Address	4-6 Minatomajima-nakamachi Chuo-ku Kobe 650-0046, Japan
TEL	078-302-4321
Email

Public contact
Name of contact person	1st name Middle name Last name Takashi Nishimura
Organization	Kobe City General Hospital
Division name	Division of Respiratory Medicine
Zip code
Address	4-6 Minatomajima-nakamachi Chuo-ku Kobe 650-0046, Japan
TEL	078-302-4321
Homepage URL
Email	t-nishi@kcgh.gr.jp

Sponsor
Institute	West Japan Oncology Group
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)

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 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 10 Month 06 Day
Date of IRB
Anticipated trial start date	2001 Year 12 Month 01 Day
Last follow-up date	2006 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2005 Year 09 Month 13 Day
Last modified on	2018 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000285

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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