UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000219 |
|---|---|
| Receipt number | R000000285 |
| 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 |
| Date of disclosure of the study information | 2005/09/13 |
| Last modified on | 2018/09/19 18:38:50 |
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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-creatinine
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
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
t-nishi@kcgh.gr.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000285
