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Ethyol (Amifostine) - Summary



ETHYOL® (amifostine) is an organic thiophosphate cytoprotective agent.

ETHYOL® (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer or non-small cell lung cancer.

ETHYOL® is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands (Clinical Studies).

For the approved indications, the clinical data do not suggest that the effectiveness of cisplatin based chemotherapy regimens or radiation therapy is altered by ETHYOL® . There are at present only limited data on the effects of ETHYOL® on the efficacy of chemotherapy or radiotherapy in other settings. ETHYOL® should not be administered to patients in other settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy, except in the context of a clinical study (see WARNINGS).

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Published Studies Related to Ethyol (Amifostine)

Subcutaneous compared with intravenous administration of amifostine in patients with head and neck cancer receiving radiotherapy: final results of the GORTEC2000-02 phase III randomized trial. [2011.01.10]
PURPOSE: To compare compliance with and efficacy of intravenous (IV) and subcutaneous (SC) amifostine for the treatment of patients undergoing radiotherapy for head and neck cancer... CONCLUSION: SC amifostine administration was not significantly superior to IV amifostine administration in terms of patient compliance or efficacy.

Amifostine does not prevent platinum-induced hearing loss associated with the treatment of children with hepatoblastoma: a report of the Intergroup Hepatoblastoma Study P9645 as a part of the Children's Oncology Group. [2009.12.15]
BACKGROUND: The current study was conducted to determine whether amifostine is effective in reducing the toxicities associated with the administration of platinum-containing regimens in children with hepatoblastoma (HB)... CONCLUSIONS: Amifostine in the doses and schedule used in this study failed to significantly reduce the incidence of platinum-induced toxicities in patients with HB. Copyright (c) 2009 American Cancer Society.

Amifostine has the potential to induce haematologic responses and decelerate disease progression in individual patients with low- and intermediate-1-risk myelodysplastic syndromes. [2009.09]
Myelodysplastic syndromes (MDS) are characterized by hypercellular bone marrow, peripheral cytopenia and an increased rate of intramedullary apoptosis. Oxidative stress is known as an important factor that leads to apoptosis in MDS.

Randomized phase 2 study of subcutaneous amifostine versus epoetin-alpha given 3 times weekly during concurrent chemotherapy and hyperfractionated radiotherapy for limited-disease small cell lung cancer. [2008.10.01]
BACKGROUND: The purpose of the current study was to investigate the role of amifostine and epoetin-alpha in reducing severe toxicities during concurrent chemo-hyperfractionated radiotherapy (CCRT) for limited disease small cell lung cancer (LD-SCLC)... CONCLUSIONS: Although amifostine administered 3 times weekly during CCRT did not significantly reduce severe toxicities, epoetin-alpha was effective in preventing severe anemia during CCRT in patients with LD-SCLC. Other radioprotective strategies to minimize severe toxicities should be investigated.

Toxicity prevention with amifostine in pediatric osteosarcoma patients treated with cisplatin and doxorubicin. [2007.09]
Amifostine has emerged as a pancytoprotectant shown protection against nephrotoxicity, neurotoxicity and ototoxicity in preclinical studies... CONCLUSION: amifostine did not reduce the ototoxicity and nephrotoxicity of our treatment regime. It was not well tolerated due to emesis. It is a selective cytoprotectant without reducing the effect of chemotherapy.

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Clinical Trials Related to Ethyol (Amifostine)

Amifostine Plus Irinotecan in Treating Patients With Metastatic Colorectal Cancer [Completed]
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus irinotecan in treating patients with metastatic colorectal cancer.

Amifostine in Treating Patients With Myelodysplastic Syndrome [Completed]
RATIONALE: Amifostine may improve blood counts in patients with myelodysplastic syndrome. PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with myelodysplastic syndrome.

Amifostine to Protect the Rectum During External Beam Radiotherapy for Prostate Cancer [Completed]
This study will evaluate the safety and effectiveness of a drug called amifostine in reducing the bowel side effects of radiation treatment for prostate cancer. Amifostine is a 'radioprotector' medicine that to protects normal tissue from radiation damage. This study will determine whether placing amifostine in the rectum during radiation treatment for prostate cancer can decrease common side effects of treatment, including diarrhea, painful bowel movements, bleeding, and gas. Patients 18 years of age or older with prostate cancer may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, bone scan if a recent one is not available, and possibly computed tomography (CT) and magnetic resonance imaging (MRI) scans of the pelvis. They will also have a liquid retention test, in which they are given an enema of 4 tablespoons of salt water that they must retain for 20 minutes. Participants will receive standard radiation therapy for prostate cancer-5 consecutive days for 8 weeks-in the National Institutes of Health (NIH) Radiation Oncology Clinic. Amifostine will be placed in the rectum by a mini-enema before each radiation treatment so that it covers the lining of the rectum. To determine the side effects of the treatment, patients will undergo a proctoscopic examination before beginning radiation therapy, two times during therapy, and at each follow-up visit for 5 years after treatment ends. This examination involves inserting a proctoscope (a thin flexible tube with a light at the end) into the rectum and taking pictures. Patients will be followed in the clinic at visits scheduled 1, 3, 6, 12, 18, 24, 36, 48, and 60 months after treatment for a physical examination and routine blood tests, proctoscopic examination, and review of bowel symptoms.

A Phase II Clinical Trial on Comparison of Effectiveness and Safeness of Different Amifostine Regimens [Recruiting]

- Radiotherapy is the primary therapeutic strategy for nasopharyngeal carcinoma.

- Radiotherapy may cause adverse effect such as xerostomia and mucositis.

- Amifostine has the ability of protecting the normal tissue but also has some side

effects. PURPOSE

- This phase II trial is to study the protecting effect and safety of different

Amifostine regimens in patients with nasopharyngeal carcinoma.

Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment [Terminated]
Primary Objective: To determine if amifostine in combination with IMRT can mitigate the decrease in production of saliva by the submandibular and sublingual salivary glands in patients with HNSCC. Secondary Objectives: 1. To establish a parotid gland dose volume histogram (DVH) versus measured flow relationship in this patient population:

- When the mean dose is < 24-26 Gy (shift recovery time to left)

- When the mean dose is > 24-26 Gy (DVH shift)

2. To observe mucositis in the following lower dose RT areas:

- Upper lip

- Lower lip

- Right cheek

- Left cheek

- Right ventral and lateral tongue

- Left ventral and lateral tongue

- Floor of the mouth

- Soft palate

- Hard palate.

3. To observe the incidence and patterns of occipital scalp epilation; 4. To observe the incidence of dysphagia using the List Performance Status Scale (LPSS); and 5. To further evaluate the safety profile of amifostine in this patient population.

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Page last updated: 2011-12-09

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