Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer (cardioprotec)

This study has been terminated.
(Enrolled too slow)
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT00955890
First received: August 7, 2009
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. CTnT/cTnI/ANP/BNP were proved to be used as a biomarker of drug related cardiotoxicity. There are excellent correlations between the total cumulative dose of doxorubicin, the severity of the resulting cardiomyopathy, and the level of serum troponin-T.


Condition Intervention Phase
Breast Cancer
Drug: Dexrazoxane hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial Of Interventional Therapy Investigate Cardiac Protection of Dexrazoxane In Women With Breast Cancer Having Experienced Grade 1 Cardiotoxicity During Prior Anthracycline-based Chemotherapy.

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Occurence of cardiac toxicity in patients with breast cancer receiving anthracycline chemotherapy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Relationship between serum level of cTnT/cTnI/ANP/BNP and cardiac toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: June 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control arm
anthracycline chemotherapy only
Experimental: low dose dexrazoxane group
anthracycline chemotherapy plus low dose dexrazoxane(10:1)
Drug: Dexrazoxane hydrochloride
pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks
Other Name: Dexrazoxane for Injection
Experimental: middle dose dexrazoxane group
anthracycline chemotherapy plus middle dose dexrazoxane(15:1)
Drug: Dexrazoxane hydrochloride
pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks
Other Name: Dexrazoxane for Injection
Drug: Dexrazoxane hydrochloride
pink powder 250mg/bottle DEX:EPI,15:1 every 3 weeks
Other Name: dexrazoxane injection

Detailed Description:

Patients with breast cancer receiving anthracycline chemotherapy randomized to 3 groups:chemotherapy plus low dose dexrazoxane,chemotherapy plus middle dose dexrazoxane, chemotherapy only.Every patient receive at least 2 cycles anthracycline chemotherapy.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary infiltrating adenocarcinoma of the breast

    • Confirmed by core needle biopsy or incisional biopsy or surgery
    • Experienced grade 1 cardiac toxicity during prior anthracycline-based chemotherapy
    • At least 2 cycles same anthracycline based chemotherapy are needed

Exclusion Criteria:

  • Accumulated dose of EPI ≥1000mg/m2,ADM≥550mg/m2
  • With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension); Prior or Concurrent radiation to heart
  • Pregnant or nursing
  • Other currently active malignancy except nonmelanoma skin cancer
  • Uncontrolled or severe bleeding,diarrhea,intestinal obstruction
  • Grade 2 or more Cardiac Toxicity (CTC AE3.0)
  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: NCT00955890

Locations
China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: xichun Hu, MD member of Fudan University
  More Information

No publications provided

Responsible Party: Xichun Hu, Dr, Fudan University
ClinicalTrials.gov Identifier: NCT00955890     History of Changes
Other Study ID Numbers: MBC0901 FUCH
Study First Received: August 7, 2009
Last Updated: February 27, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
cardioprotection
anthracycline chemotherapy
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Dexrazoxane
Razoxane
Antimitotic Agents
Antineoplastic Agents
Cardiotonic Agents
Cardiovascular Agents
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 20, 2014