A Combination of Abraxane and Cisplatin in Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT01149798
First received: June 23, 2010
Last updated: August 5, 2012
Last verified: August 2012
  Purpose

This phase II trial on the assumption that abraxane and cisplatin combination therapy is efficacy in metastatic breast cancer.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Abraxane and Cisplatin combination
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Institutional Phase II Clinical Trial of Abraxane Combined With Cisplatin in Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Fudan University:

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 ]

Enrollment: 73
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Other Names:
  • Abraxane
  • Cisplatin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01149798

Locations
China
Fudan University Cancer Hospital
Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Study Chair: Xichun Hu Fudan University
  More Information

No publications provided

Responsible Party: Xichun Hu, Dr, Fudan University
ClinicalTrials.gov Identifier: NCT01149798     History of Changes
Other Study ID Numbers: Fudan BR2010-02
Study First Received: June 23, 2010
Last Updated: August 5, 2012
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
metastatic breast cancer
combined chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014