Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer - Full Text View

Sponsored by:	Fudan University
Information provided by:	Fudan University
ClinicalTrials.gov Identifier:	NCT00955890

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
Cardioprotection	Drug: Dexrazoxane hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: ICRF 159 Razoxane Dexrazoxane Dexrazoxane hydrochloride

U.S. FDA Resources

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 ]

Estimated Enrollment:	183
Study Start Date:	June 2009
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
control arm: No Intervention anthracycline chemotherapy only
low dose dexrazoxane group: Experimental anthracycline chemotherapy plus low dose dexrazoxane(10:1)	Drug: Dexrazoxane hydrochloride pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks
middle dose dexrazoxane group: Experimental anthracycline chemotherapy plus middle dose dexrazoxane(15:1)	Drug: Dexrazoxane hydrochloride pink power 250mg/bottle DEX:EPI,10:1 every 3 weeks Drug: Dexrazoxane hydrochloride pink powder 250mg/bottle DEX:EPI,15:1 every 3 weeks

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

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Female

Menopausal status:

Not specified

Life expectancy:

Longer than 3 months

Hematopoietic:

Granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3
Hemoglobin at least 80*10^12/mm3

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST no greater than 2.5 times ULN

Renal:

Creatinine no greater than 1.5 times ULN

Other:

Fertile patients must use effective contraception
Patients taking tamoxifen must use effective nonhormonal contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Prior chemotherapy were allowed
At least 2 more cycled anthracycline based chemotherapy same as prior chemotherapy that induced grade 1 cardiac events were needed
No other concurrent chemotherapy

Endocrine therapy:

Prior tamoxifen or raloxifene allowed
Concurrent tamoxifen or raloxifene allowed
No other concurrent hormonal therapy except for steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic

Radiotherapy:

Prior radiotherapy for index malignancy allowed exclude radiation to heart

Surgery:

See Disease Characteristics
Prior surgery for breast cancer was allowed

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955890

Contacts

Contact: haiyi guo, MD

86(021)64175590 ext 5008

guohaiyi@csco.org.cn

Locations

China
Fudan University Cancer Hospital	Recruiting
Shanghai, China, 200032
Contact: Haiyi guo, MD 86(021)64175590 ext 5000 guohaiyi@csco.org.cn
Sub-Investigator: Haiyi Guo, MD

Sponsors and Collaborators

Fudan University

Investigators

Principal Investigator:

xichun Hu, MD

member of Fudan University

More Information

No publications provided

Responsible Party:	Fudan University Cancer Hospital ( Haiyi Guo )
Study ID Numbers:	MBC0901 FUCH
Study First Received:	August 7, 2009
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00955890 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Fudan University:

cardioprotection
anthracycline chemotherapy
breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Chelating Agents

Cardiovascular Agents
Breast Diseases
Razoxane

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Breast Neoplasms
Chelating Agents
Cardiovascular Agents
Pharmacologic Actions
Breast Diseases
Razoxane

ClinicalTrials.gov processed this record on September 11, 2009