A Combination of Abraxane and Cisplatin in Metastatic Breast Cancer | RxWiki

A Combination of Abraxane and Cisplatin in Metastatic Breast Cancer

Overview[ - collapse ][ - ]

Purpose	This phase II trial on the assumption that abraxane and cisplatin combination therapy is efficacy in metastatic breast cancer.
Condition	Metastatic Breast Cancer
Intervention	Drug: Abraxane and Cisplatin combination
Phase	Phase 2
Sponsor	Fudan University
Responsible Party	Fudan University
ClinicalTrials.gov Identifier	NCT01149798
First Received	June 23, 2010
Last Updated	August 5, 2012
Last verified	August 2012

Tracking Information[ + expand ][ + ]

First Received Date	June 23, 2010
Last Updated Date	August 5, 2012
Start Date	June 2010
Estimated Primary Completion Date	November 2011
Current Primary Outcome Measures	Overall response rates (ORR) of abraxane and cisplatin combination therapy [Time Frame: 2months] [Designated as safety issue: No]
Current Secondary Outcome Measures	Progression free Suivial (PFS) [Time Frame: 6 months] [Designated as safety issue: Yes] Number of adverse event [Time Frame: 2 months] [Designated as safety issue: Yes] Overrall Survival (OS) [Time Frame: 12 months] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	A Combination of Abraxane and Cisplatin in Metastatic Breast Cancer
Official Title	A Single Institutional Phase II Clinical Trial of Abraxane Combined With Cisplatin in Metastatic Breast Cancer
Brief Summary	This phase II trial on the assumption that abraxane and cisplatin combination therapy is efficacy in metastatic breast cancer.
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
Study Phase	Phase 2
Study Design	Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Metastatic Breast Cancer
Intervention	Drug: Abraxane and Cisplatin combination 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: Abraxane Cisplatin
Study Arm (s)	Experimental: Abraxane and Cisplatin combination Abraxane and Cisplatin combination

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	73
Estimated Completion Date	November 2011
Estimated Primary Completion Date	June 2011
Eligibility Criteria	Inclusion Criteria: - Subject must fulfill all of the following conditions or characteristics in order to be considered for study enrollment: 1. 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. 2. At least one measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST). 3. Histopathologically or cytologically confirmed breast cancer. 4. Female at an age of ≥18 years. 5. 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. 6. 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 7. ECOG performance status of 0, 1 or 2. 8. A life expectancy of more than 3 months. Exclusion Criteria: 1. Pregnant or breast-feeding women. 2. Positive serum pregnancy test. 3. Unwilling to use a medically acceptable form of contraception, except for those who were surgically sterile or at least 1 year postmenopausal. 4. 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. 5. Meningeal metastases. 6. Radiotherapy within the 4 weeks preceding study treatment start. 7. Incomplete recovery from the effects of major surgery. 8. Prior hormonal treatment allowed but must be discontinued 14 days prior to study entry. 9. Participation in any investigational drug study within 4 weeks preceding treatment start. 10. Blood transfusions or growth factors to aid hematological recovery within 2 weeks prior to study treatment start. 11. Significant medical condition that would make treatment or follow-up on this protocol difficult or problematic in the opinion of the treating oncologist. 12. 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. 13. Serious uncontrolled intercurrent infections. 14. Poor compliance.
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	China

Administrative Information[ + expand ][ + ]

NCT Number	NCT01149798
Other Study ID Numbers	Fudan BR2010-02
Has Data Monitoring Committee	No
Information Provided By	Fudan University
Study Sponsor	Fudan University
Collaborators	Not Provided
Investigators	Study Chair: Xichun Hu Fudan University
Verification Date	August 2012

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