- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01149798
A Combination of Abraxane and Cisplatin in Metastatic Breast Cancer
August 5, 2012 updated by: Xichun Hu, Fudan University
A Single Institutional Phase II Clinical Trial of Abraxane Combined With Cisplatin in Metastatic Breast Cancer
This phase II trial on the assumption that abraxane and cisplatin combination therapy is efficacy in metastatic breast cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The rationales for the combination of Abraxane and cisplatin include that either drug has antitumor activity; they have different mechanisms; no cross-resistance are documented between them, and there have been some preclinical evidences indicating synergistic effects between the two agents.
This phase II study will be undertaken to evaluate combination of cisplatin and weekly abraxane in terms of efficacy and safety in MBC patients.
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Shanghai, China, 200032
- Fudan University Cancer Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Subject must fulfill all of the following conditions or characteristics in order to be considered for study enrollment:
- Written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time without prejudice.
- At least one measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST).
- Histopathologically or cytologically confirmed breast cancer.
- Female at an age of ≥18 years.
- Prior taxane or platinum treatment allowed. However, the drug interval should be longer than 12 months in adjuvant/neo-adjuvant setting and three months in MBC patients who have obtained ORR with taxane- or platinum-containing regimens.
The lab values within 2 weeks prior to trial should meet:
- PLT ≥100,000/mm3
- ANC≥2000/mm3
- HB≥80g/L
- Total bilirubin < upper limit of normal level(UNL, < 1.5 x UNL for patients with liver metastasis)
- ALT/AST < 1.5 x UNL (< 2.5 x UNL for patients with liver metastasis)
- AKP < 5 x UNL (except for patients with bone metastasis)
- Serum creatinine < UNL
- ECOG performance status of 0, 1 or 2.
- A life expectancy of more than 3 months.
Exclusion Criteria:
- Pregnant or breast-feeding women.
- Positive serum pregnancy test.
- Unwilling to use a medically acceptable form of contraception, except for those who were surgically sterile or at least 1 year postmenopausal.
- Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling.
- Meningeal metastases.
- Radiotherapy within the 4 weeks preceding study treatment start.
- Incomplete recovery from the effects of major surgery.
- Prior hormonal treatment allowed but must be discontinued 14 days prior to study entry.
- Participation in any investigational drug study within 4 weeks preceding treatment start.
- Blood transfusions or growth factors to aid hematological recovery within 2 weeks prior to study treatment start.
- Significant medical condition that would make treatment or follow-up on this protocol difficult or problematic in the opinion of the treating oncologist.
- Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer.
- Serious uncontrolled intercurrent infections.
- Poor compliance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Abraxane and Cisplatin combination
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Abraxane will be given at 125 mg/m2, venous infusion within 30 minutes, administered on days 1, 8 and 15. Cisplatin at 75mg/m2, venous infusion for 120 minutes, will be administered on day 1.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall response rates (ORR) of abraxane and cisplatin combination therapy
Time Frame: 2months
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2months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression free Suivial (PFS)
Time Frame: 6 months
|
6 months
|
Number of adverse event
Time Frame: 2 months
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2 months
|
Overrall Survival (OS)
Time Frame: 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Xichun Hu, Fudan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Li Y, Zhao Y, Gong C, Xie Y, Hu X, Zhang J, Wang L, Zhang S, Cao J, Tao Z, Wang B. Cisplatin shows greater efficacy than gemcitabine when combined with nab-paclitaxel in metastatic triple-negative breast cancer. Sci Rep. 2019 Mar 5;9(1):3563. doi: 10.1038/s41598-019-39314-y.
- Tang LC, Wang BY, Sun S, Zhang J, Jia Z, Lu YH, Di GH, Shao ZM, Hu XC. Higher rate of skin rash in a phase II trial with weekly nanoparticle albumin-bound paclitaxel and cisplatin combination in Chinese breast cancer patients. BMC Cancer. 2013 May 9;13:232. doi: 10.1186/1471-2407-13-232.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
June 23, 2010
First Submitted That Met QC Criteria
June 23, 2010
First Posted (Estimate)
June 24, 2010
Study Record Updates
Last Update Posted (Estimate)
August 7, 2012
Last Update Submitted That Met QC Criteria
August 5, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fudan BR2010-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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