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

This study has been completed.
Sponsor:
Collaborator:
Istituto Superiore di Sanità
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT01069081
First received: February 10, 2010
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Breast Cancer
Metastasis, Neoplasm
Drug: Arm C
Drug: Arm B
Drug: Arm A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Time to progression [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to treatment failure,Objective response,Overall survival,Safety [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

Enrollment: 94
Study Start Date: August 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069081

Locations
China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
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
  More Information

No publications provided

Responsible Party: Xichun Hu, Dr, Fudan University
ClinicalTrials.gov Identifier: NCT01069081     History of Changes
Other Study ID Numbers: Fudan BR2010-01
Study First Received: February 10, 2010
Last Updated: July 27, 2012
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Metastasis Breast Cancer
Proton Pump Inhibitor
Chemotherapy
Phase II study
TTP

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Breast Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Skin Diseases
Cisplatin
Docetaxel
Esomeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Antimitotic Agents
Antineoplastic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014