Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer

NCT00955890 | Terminated Phase 2 DMC

• 1 other identifier: MBC0901 FUCH
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

cardioprotection; anthracycline chemotherapy; breast cancer

Outcome Measures

Primary Outcomes (1)

• Occurence of cardiac toxicity in patients with breast cancer receiving anthracycline chemotherapy

  1 year

Secondary Outcomes (1)

• Relationship between serum level of cTnT/cTnI/ANP/BNP and cardiac toxicity

  1 year

Study Arms (3)

control arm

NO INTERVENTION

anthracycline chemotherapy only

low dose dexrazoxane group

EXPERIMENTAL

anthracycline chemotherapy plus low dose dexrazoxane(10:1)

Drug: Dexrazoxane hydrochloride

middle dose dexrazoxane group

EXPERIMENTAL

anthracycline chemotherapy plus middle dose dexrazoxane(15:1)

Drug: Dexrazoxane hydrochloride

Interventions

Dexrazoxane hydrochloride DRUG

pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks

Also known as: Dexrazoxane for Injection

low dose dexrazoxane group; middle dose dexrazoxane group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dexrazoxane; Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Razoxane; Diketopiperazines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• xichun Hu, MD

  member of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 10, 2009
• Study Start: June 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

CN (1)