Docetaxel and Cisplatin Chemotherapy With or Without High Dose Proton Pump Inhibitor in Metastatic Breast Cancer
Primary Purpose
Breast Cancer, Metastasis, Neoplasm
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Arm C
Arm B
Arm A
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Metastasis Breast Cancer, Proton Pump Inhibitor, Chemotherapy, Phase II study, TTP
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent.
- Female, ≥ 18 years.
- Histologically confirmed invasive breast cancer.
- Metastatic breast cancer.
- Karnofsky Performance Status ≥60.
- Life expectancy of more than 3 months.
- Subject must have adequate organ function.
- Normal laboratory values: hemoglobin > 80g/dl, neutrophils > 2.0×10^9/L, platelets > 80×10^9/L, serum creatinine < upper limit of normal (ULN), serum bilirubin < ULN, ALT and AST < 2.5×ULN, AKP < 5×ULN.
- Negative serum pregnancy test for women with childbearing potential.
- Good conditions for infusion and willing to have phlebotomy throughout whole study.
- Have ceased anti-tumor treatments including endocrinotherapy and bio-targeted therapy for more than 28 days.
- Have at least one target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- No prior use of docetaxel or has used docetaxel in adjuvant/neo-adjuvant chemotherapy and has a relapse free survival of at least 12 months.
Exclusion Criteria:
- Pregnant or lactating females.
- History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
- Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety.
- Active or uncontrolled infection.
- Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
- Concomitant with brain metastases.
- Have received chemotherapy after metastasis.
Sites / Locations
- Fudan University Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
arm A
arm B
arm C
Arm Description
docetaxel and cisplatin chemotherapy
docetaxel and cisplatin chemotherapy combined with PPI 160mg per day.
docetaxel and cisplatin chemotherapy combined with PPI 200mg per day.
Outcomes
Primary Outcome Measures
Time to progression
Secondary Outcome Measures
Time to treatment failure,Objective response,Overall survival,Safety
Full Information
NCT ID
NCT01069081
First Posted
February 10, 2010
Last Updated
March 4, 2015
Sponsor
Fudan University
Collaborators
Istituto Superiore di Sanità
1. Study Identification
Unique Protocol Identification Number
NCT01069081
Brief Title
Docetaxel and Cisplatin Chemotherapy With or Without High Dose Proton Pump Inhibitor in Metastatic Breast Cancer
Official Title
Phase II Study of Docetaxel and Cisplatin Chemotherapy Versus Docetaxel and Cisplatin Chemotherapy Combined With High Dose Proton Pump Inhibitor in Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Istituto Superiore di Sanità
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objectives of this study are to evaluate the efficacy and tolerability of high dose proton pump inhibitor combined with chemotherapy in metastatic breast cancer.
Detailed Description
High dose proton pump inhibitor (PPI) has been proved beneficial and it improved efficacy when combined with chemotherapy in preclinical and clinical trials.This study was designed to explore whether adding a proton pump inhibitor into docetaxel and cisplatin chemotherapy improves efficacy and does not affect tolerability in metastatic breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Metastasis, Neoplasm
Keywords
Metastasis Breast Cancer, Proton Pump Inhibitor, Chemotherapy, Phase II study, TTP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
arm A
Arm Type
Active Comparator
Arm Description
docetaxel and cisplatin chemotherapy
Arm Title
arm B
Arm Type
Experimental
Arm Description
docetaxel and cisplatin chemotherapy combined with PPI 160mg per day.
Arm Title
arm C
Arm Type
Experimental
Arm Description
docetaxel and cisplatin chemotherapy combined with PPI 200mg per day.
Intervention Type
Drug
Intervention Name(s)
Arm C
Other Intervention Name(s)
docetaxel, cisplatin, esomeprazole
Intervention Description
Docetaxel and cisplatin chemotherapy combined with high dose PPI. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.PPI 200mg p.o. d1-3 every week for 66 weeks.
Intervention Type
Drug
Intervention Name(s)
Arm B
Other Intervention Name(s)
Docetaxel, cisplatin, esomeprazole
Intervention Description
Docetaxel and cisplatin chemotherapy combined with lower dose PPI. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.PPI 160mg p.o. d1-3 every week for 66 weeks.
Intervention Type
Drug
Intervention Name(s)
Arm A
Other Intervention Name(s)
Docetaxel, Cisplatin
Intervention Description
Docetaxel and cisplatin chemotherapy. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.
Primary Outcome Measure Information:
Title
Time to progression
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Time to treatment failure,Objective response,Overall survival,Safety
Time Frame
six weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent.
Female, ≥ 18 years.
Histologically confirmed invasive breast cancer.
Metastatic breast cancer.
Karnofsky Performance Status ≥60.
Life expectancy of more than 3 months.
Subject must have adequate organ function.
Normal laboratory values: hemoglobin > 80g/dl, neutrophils > 2.0×10^9/L, platelets > 80×10^9/L, serum creatinine < upper limit of normal (ULN), serum bilirubin < ULN, ALT and AST < 2.5×ULN, AKP < 5×ULN.
Negative serum pregnancy test for women with childbearing potential.
Good conditions for infusion and willing to have phlebotomy throughout whole study.
Have ceased anti-tumor treatments including endocrinotherapy and bio-targeted therapy for more than 28 days.
Have at least one target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
No prior use of docetaxel or has used docetaxel in adjuvant/neo-adjuvant chemotherapy and has a relapse free survival of at least 12 months.
Exclusion Criteria:
Pregnant or lactating females.
History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety.
Active or uncontrolled infection.
Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
Concomitant with brain metastases.
Have received chemotherapy after metastasis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiChun Hu, MD,Ph. D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Chiesi
Organizational Affiliation
Istituto Superiore di Sanità
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefano Fais, MD PHD
Organizational Affiliation
Istituto Superiore di Sanità
Official's Role
Study Director
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
26297142
Citation
Wang BY, Zhang J, Wang JL, Sun S, Wang ZH, Wang LP, Zhang QL, Lv FF, Cao EY, Shao ZM, Fais S, Hu XC. Intermittent high dose proton pump inhibitor enhances the antitumor effects of chemotherapy in metastatic breast cancer. J Exp Clin Cancer Res. 2015 Aug 22;34(1):85. doi: 10.1186/s13046-015-0194-x. Erratum In: J Exp Clin Cancer Res. 2015;34:109.
Results Reference
derived
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Docetaxel and Cisplatin Chemotherapy With or Without High Dose Proton Pump Inhibitor in Metastatic Breast Cancer
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