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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006019
Receipt No. R000005291
Scientific Title Phase I/II study of Gemcitabine plus weekly Paclitaxel with Metastatic Breast Cancer
Date of disclosure of the study information 2011/07/22
Last modified on 2018/02/09

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Basic information
Public title Phase I/II study of Gemcitabine plus weekly Paclitaxel with Metastatic Breast Cancer
Acronym Phase I/II study of Gemcitabine plus weekly Paclitaxel with Metastatic Breast Cancer
Scientific Title Phase I/II study of Gemcitabine plus weekly Paclitaxel with Metastatic Breast Cancer
Scientific Title:Acronym Phase I/II study of Gemcitabine plus weekly Paclitaxel with Metastatic Breast Cancer
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate maximum tolerated dose to determine recommended dose of gemcitabine and weekly paclitaxel in inoperable and/or metastatic breast cancer patients. In the next phase, we evaluate the safety and efficacy with recommended dose for these patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes To determine maximum tolerated dose and recommended dose
Key secondary outcomes adverse events
time to progression

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 optimal dosage of gemcitabine plus paclitaxel is decided by the dose limiting toxicity
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
20 years-old <=
Age-upper limit
75 years-old >
Gender Female
Key inclusion criteria histologically or cytologically confirmed locally advanced breast cancer or metastatic breast cancer

HER2 negative

over 20 years old, under 75 years old

ECOG performance status--0 or 1

All Pts are
1--after receiving anthracycline containing regimen for neoadjuvant and adjuvant setting, but no prior chemotherapy for metastatic disease including taxanes must have been completed more than 12 months before registering in this study
2--after receiving one regimen for locally advanced breast cancer including taxanes must have been completed more than 12 months before registering in this study

Patients who have passed the following periods from previous treatment
1--immunotherapy/endocrinetherapy
14 days from the final administration,
in case of LH-RH analogue, 28 days are
needed
2--chemotherapy
28 days
3--radiation therapy
28 days
4--operation
7 days
Key exclusion criteria Prior administration of gemcitabine

Pulmonary fibrosis or pneumonitis

Abnormal cardiac function, myocardial infarction within 6 months

Body cavity fluid which needs to treatment

Active infection

Severe complicated situation

Severe drug allergic reaction

Serious psychiatric illness

After bone marrow transplantation

After stem cell transplantation

Symptomatic systemic brain metastasis

Double chemotherapy

Pregnancy, breast feeding, suspected pregnancy


Target sample size 47

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Suzuki
Organization Tokai University School of Medicine
Division name Division of Breast and Endocrine Surgery, Department of Surgery
Zip code
Address 143 Shimokasuya, Isehara city, Kanagawa, Japan, 259-1193
TEL +81-463-93-1121
Email luke-szk@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Suzuki
Organization Tokai University School of Medicine
Division name Division of Breast and Endocrine Surgery, Department of Surgery
Zip code
Address 143 Shimokasuya, Isehara city, Kanagawa, Japan, 259-1193
TEL +81-463-93-1121
Homepage URL
Email luke-szk@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine
Division of Breast and Endocrine Surgery
Department of Surgery
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
2011 Year 07 Month 22 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 In 1000mg/m2 of gemcitabine dose, DLT was observed in one case of 6 patienrs. This DLT was grade 4 neutropenia. And in 1250mg/m2 of gemcitabine dose, no DLT was observed. Finaly, recomended dose will be 1250mg/m2 of gemcitabine.
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
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 21 Day
Last modified on
2018 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005291

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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