A Combination of Abraxane and Cisplatin in Metastatic Breast Cancer
This study has been completed.
Information provided by (Responsible Party):
Xichun Hu, Fudan University
First received: June 23, 2010
Last updated: August 5, 2012
Last verified: August 2012
This phase II trial on the assumption that abraxane and cisplatin combination therapy is efficacy in metastatic breast cancer.
Metastatic Breast Cancer
Drug: Abraxane and Cisplatin combination
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Single Institutional Phase II Clinical Trial of Abraxane Combined With Cisplatin in Metastatic Breast Cancer
Primary Outcome Measures:
- Overall response rates (ORR) of abraxane and cisplatin combination therapy [ Time Frame: 2months ] [ Designated as safety issue: No ]
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2011 (Final data collection date for primary outcome measure)
Experimental: Abraxane and Cisplatin combination
Abraxane and Cisplatin combination
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.
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.
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149798
|Fudan University Cancer Hospital
|Shanghai, China, 200032 |
No publications provided
||Xichun Hu, Dr, Fudan University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 23, 2010
||August 5, 2012
||China: Ethics Committee
Keywords provided by Fudan University:
metastatic breast cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Neoplasms by Site
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic