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

NCT ID: NCT01069081

Last Updated: 2015-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-02-29

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.

Conditions

Breast Cancer; Metastasis, Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

arm A

docetaxel and cisplatin chemotherapy

Group Type: ACTIVE_COMPARATOR

Arm A

Intervention Type: 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.

arm B

docetaxel and cisplatin chemotherapy combined with PPI 160mg per day.

Group Type: EXPERIMENTAL

Arm B

Intervention Type: 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.

arm C

docetaxel and cisplatin chemotherapy combined with PPI 200mg per day.

Group Type: EXPERIMENTAL

Arm C

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

docetaxel; cisplatin; esomeprazole; Docetaxel; cisplatin; esomeprazole; Docetaxel; Cisplatin

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istituto Superiore di Sanità

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xichun Hu

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

XiChun Hu, MD,Ph. D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Antonio Chiesi

Role: PRINCIPAL_INVESTIGATOR

Istituto Superiore di Sanità

Stefano Fais, MD PHD

Role: STUDY_DIRECTOR

Istituto Superiore di Sanità

Locations

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 26297142 (View on PubMed)

Other Identifiers

Fudan BR2010-01

Identifier Type: -

Identifier Source: org_study_id