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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01069081
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : March 6, 2015
Sponsor:
Collaborator:
Istituto Superiore di Sanità
Information provided by (Responsible Party):
Xichun Hu, Fudan University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Metastasis, Neoplasm Drug: Arm C Drug: Arm B Drug: Arm A Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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:
  • Docetaxel
  • Cisplatin

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:
  • Docetaxel
  • cisplatin
  • 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:
  • docetaxel
  • cisplatin
  • esomeprazole




Primary Outcome Measures :
  1. Time to progression [ Time Frame: six weeks ]

Secondary Outcome Measures :
  1. Time to treatment failure,Objective response,Overall survival,Safety [ Time Frame: six weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069081


Locations
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China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Istituto Superiore di Sanità
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xichun Hu, Dr, Fudan University
ClinicalTrials.gov Identifier: NCT01069081    
Other Study ID Numbers: Fudan BR2010-01
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Keywords provided by Xichun Hu, Fudan University:
Metastasis Breast Cancer
Proton Pump Inhibitor
Chemotherapy
Phase II study
TTP
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Cisplatin
Docetaxel
Esomeprazole
Proton Pump Inhibitors
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors