NEWS HIGHLIGHTS
Published Studies Related to Zinecard (Dexrazoxane)
Multicenter randomized phase III study of the cardioprotective effect of dexrazoxane (Cardioxane) in advanced/metastatic breast cancer patients treated with anthracycline-based chemotherapy. [2006.04]
BACKGROUND: Anthracycline-induced cardiotoxicity has led to the adoption of empirical dose limits that may restrict continued use of anthracyclines among patients who might benefit. Dexrazoxane, a cardioprotective agent, has been shown to reduce the risk of anthracycline-associated cardiotoxicity when given from first dose of anthracycline. This study sought to confirm the benefit of dexrazoxane in patients at high risk of cardiotoxicity due to prior anthracycline use... CONCLUSION: Dexrazoxane significantly reduced the occurrence and severity of anthracycline-induced cardiotoxicity in patients at increased risk of cardiac dysfunction due to previous anthracycline treatment without compromising the antitumor efficacy of the chemotherapeutic regimen.
Effect of epirubicin-based chemotherapy and dexrazoxane supplementation on QT dispersion in non-Hodgkin lymphoma patients. [2005.12]
BACKGROUND AND OBJECTIVE: Aim of the present study was to assess the effect of epirubicin-based chemotherapy on QT interval dispersion in patients with aggressive non-Hodgkin lymphoma (NHL), and the effect of dexrazoxane supplementation. Prolongation of QT dispersion may not only represent a sensitive tool in identifying the first sign of anthracycline-induced cardiotoxicity, but it may serve also in identifying patients who are at risk of arrhythmic events... CONCLUSIONS: Epirubicin-based chemotherapy causes an early increase of the QT and QTc dispersion, which is attenuated by dexrazoxane supplementation. Therefore, dexrazoxane can reduce the arrhythmic risk in patients treated with epirubicin.
The effect of dexrazoxane on myocardial injury in doxorubicin-treated children with acute lymphoblastic leukemia. [2004.07.08]
BACKGROUND: Doxorubicin chemotherapy is very effective in children with acute lymphoblastic leukemia (ALL) but also injures myocardial cells. Dexrazoxane, a free-radical scavenger, may protect the heart from doxorubicin-associated damage... CONCLUSIONS: Dexrazoxane prevents or reduces cardiac injury, as reflected by elevations in troponin T, that is associated with the use of doxorubicin for childhood ALL without compromising the antileukemic efficacy of doxorubicin. Longer follow-up will be necessary to determine the influence of dexrazoxane on echocardiographic findings at four years and on event-free survival. Copyright 2004 Massachusetts Medical Society
Effect of dexrazoxane on homocysteine-induced endothelial dysfunction in normal subjects. [2002.07.01]
CONCLUSIONS: Administration of the novel antioxidant agent dexrazoxane prevents homocysteine-induced impairment of vascular endothelial function in the brachial artery of healthy subjects.
Comparative open, randomized, cross-over bioequivalence study of two intravenous dexrazoxane formulations (Cardioxane and ICRF-187) in patients with advanced breast cancer, treated with 5-fluorouracil-doxorubicin-cyclophosphamide (FDC). [1999.01]
The purpose of this study was to compare the pharmacokinetic disposition of two intravenous dexrazoxane formulations, and their effects on doxorubicin's kinetics and metabolism. Plasma concentration versus time curves and pharmacokinetic parameters of dexrazoxane given as Cardioxane (dexrazoxane hydrochloride salt) and ICRF-187 reference formulation (dexrazoxane base) were determined and compared...
Clinical Trials Related to Zinecard (Dexrazoxane)
Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients [Recruiting]
Objectives:
1. To determine if dose intensive Vincristine, Doxorubicin, Cyclophosphamide and
Dexrazoxane (VACdxr) with or without ImmTherTM can improve the 2-year disease-free
survival seen with standard VAC therapy.
2. To evaluate the feasibility and describe the toxicity associated with VACdxr.
3. To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a
weekly basis for 50- 52 weeks.
4. To determine which therapy (VACdxr+ or VACdxr-) is worthy of further evaluation.
Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer [Recruiting]
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.
Dexrazoxane and Cisplatin in Treating Patients With Advanced Solid Tumors [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy, such as dexrazoxane and cisplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may help kill more tumor
cells.
PURPOSE: This phase I trial is studying the side effects and best dose of dexrazoxane when
given together with cisplatin in treating patients with advanced solid tumors.
Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer [Completed]
RATIONALE: 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. It is
not yet known if chemotherapy combined with surgery and radiation therapy is more effective
with or without dexrazoxane and trastuzumab in treating breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy,
surgery, and radiation therapy with or without dexrazoxane and trastuzumab in treating women
who have stage IIIA, stage IIIB or stage IV breast cancer.
Obatoclax Mesylate, Vincristine Sulfate, Doxorubicin Hydrochloride, and Dexrazoxane Hydrochloride in Treating Young Patients With Relapsed or Refractory Solid Tumors, Lymphoma, or Leukemia [Recruiting]
RATIONALE: Obatoclax mesylate may stop the growth of cancer cells by blocking some of the
proteins needed for cell growth and causing the cells to self-destruct. Drugs used in
chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, and dexrazoxane
hydrochloride, work in different ways to stop the growth of cancer cells, either by killing
the cells or by stopping them from dividing. Giving obatoclax mesylate together with
combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of obatoclax mesylate
when given together with vincristine sulfate, doxorubicin hydrochloride, and dexrazoxane
hydrochloride in treating young patients with relapsed or refractory solid tumors, lymphoma,
or leukemia.
|
