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Completed

NCT Number: NCT01069081

Docetaxel and Cisplatin Chemotherapy With or Without 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Metastasis, Neoplasm Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARM C

Drug

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

ARM B

Drug

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

ARM A

Drug

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

Primary outcomes

  1. Time to progression

    Time frame: six weeks

Secondary outcomes

  1. Time to treatment failure,Objective response,Overall survival,Safety

    Time frame: six weeks

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • Istituto Superiore di Sanità

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 17, 2010
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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