UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006019 |
|---|---|
| Receipt number | 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 09:29:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
luke-szk@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Division of Breast and Endocrine Surgery
Department of Surgery
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005291
