Back to results

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

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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

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

Learn more about this trial

Docetaxel and Cisplatin Chemotherapy With or Without High Dose Proton Pump Inhibitor in Metastatic Breast Cancer

We'll reach out to this number within 24 hrs