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

March 4, 2015 updated by: Xichun Hu, Fudan University

Phase II Study of Docetaxel and Cisplatin Chemotherapy Versus Docetaxel and Cisplatin Chemotherapy Combined With High Dose Proton Pump Inhibitor in Metastatic Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: arm A
docetaxel and cisplatin chemotherapy
Drug: Arm A
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.
Other Names:
  • Cisplatin
  • Docetaxel
EXPERIMENTAL: arm B
docetaxel and cisplatin chemotherapy combined with PPI 160mg per day.
Drug: Arm B
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.
Other Names:
  • cisplatin
  • Docetaxel
  • esomeprazole
EXPERIMENTAL: arm C
docetaxel and cisplatin chemotherapy combined with PPI 200mg per day.
Drug: Arm C
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.
Other Names:
  • cisplatin
  • esomeprazole
  • docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: six weeks
six weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to treatment failure,Objective response,Overall survival,Safety
Time Frame: six weeks
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Istituto Superiore di Sanità

Investigators

  • Principal Investigator: XiChun Hu, MD,Ph. D, Fudan University
  • Principal Investigator: Antonio Chiesi, Istituto Superiore di Sanità
  • Study Director: Stefano Fais, MD PHD, Istituto Superiore di Sanità

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

February 10, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (ESTIMATE)

February 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fudan BR2010-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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