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

NCT01069081 | Completed Phase 2 DMC

• 1 other identifier: Fudan BR2010-01
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Metastasis, Neoplasm

Keywords

Metastasis Breast Cancer; Proton Pump Inhibitor; Chemotherapy; Phase II study; TTP

Outcome Measures

Primary Outcomes (1)

• Time to progression

  six weeks

Secondary Outcomes (1)

• Time to treatment failure,Objective response,Overall survival,Safety

  six weeks

Study Arms (3)

arm A

ACTIVE COMPARATOR

docetaxel and cisplatin chemotherapy

Drug: Arm A

arm B

EXPERIMENTAL

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

Drug: Arm B

arm C

EXPERIMENTAL

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

Drug: Arm C

Interventions

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.

Also known as: docetaxel, cisplatin, esomeprazole

arm C

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.

Also known as: Docetaxel, cisplatin, esomeprazole

arm B

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.

Also known as: Docetaxel, Cisplatin

arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead
• Istituto Superiore di Sanità: collaborator

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• 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.

  PMID: 26297142 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Docetaxel; Cisplatin; Esomeprazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• XiChun Hu, MD,Ph. D

  Fudan University

  PRINCIPAL INVESTIGATOR

• Antonio Chiesi

  Istituto Superiore di Sanità

  PRINCIPAL INVESTIGATOR

• Stefano Fais, MD PHD

  Istituto Superiore di Sanità

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 17, 2010
• Study Start: August 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

CN (1)