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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069081
• Other study ID #: Fudan BR2010-01
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2010
• Last updated: March 4, 2015
• Start date: August 2009
• Est. completion date: February 2012

Study information

• Verified date: March 2015
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastasis, Neoplasm
• Neoplasm Metastasis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Istituto Superiore di Sanità

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression		six weeks	Yes
Secondary	Time to treatment failure,Objective response,Overall survival,Safety		six weeks	Yes