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Also known as Ethyo
Amifostine · 2 trials · 8 indications
| Arm | Type | Description |
|---|---|---|
| Arm A Amifostine | ACTIVE_COMPARATOR | Patients with newly diagnosed, locally advanced stage ill or IV SCCHN received; * 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system). * Subcutaneous daily amifostine at a dose of 500 mg |
| Arm B No-Amifostine | EXPERIMENTAL | Patients with newly diagnosed, locally advanced stage ill or IV SCCHN \- 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system). |
| Name | Type | Description |
|---|---|---|
| Amifostine | DRUG | Given subcutaneously |
| Carboplatin | DRUG | Given IV |
| Paclitaxel | DRUG | Given IV |
| radiation | RADIATION | Given once daily for 4 weeks and then twice daily for 2 weeks. |
Inclusion Criteria * Histologically or cytologically proven squamous cell carcinoma of the head and neck. Biopsy is preferred unless medically contraindicated. * Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be inc...
Amifostine is being studied to reduce toxicity caused by chemotherapy and radiation therapy. Its investigated uses include chemotherapeutic agent toxicity, esophagitis, mucositis, xerostomia, radiation toxicity, and pneumonitis in patients with head and neck cancer or unresectable non-small cell lung cancer.
AstraZeneca PLC, which trades under the ticker AZN, is the developer associated with Amifostine. The company is listed as the sponsor of the clinical program evaluating the drug in oncology settings, including prevention of treatment-related toxicities from chemotherapy and radiation.
Amifostine is in Phase 2 clinical development. It is investigational and has not been approved for the studied uses. The program includes completed Phase 2 trials, with no active trials currently listed, and the studies together enrolled 130 patients.
Amifostine has been evaluated in two completed Phase 2 trials. NCT00095927 was a randomized study of Amifostine for squamous cell carcinoma of the head and neck, enrolling 58 patients. NCT00081315 studied subcutaneous Amifostine in patients with unresectable non-small cell lung cancer, enrolling 130 patients.
Amifostine is a small molecule studied for reducing toxicity from chemotherapy and radiation. In the Phase 2 program it was given to patients with head and neck cancer or unresectable non-small cell lung cancer to evaluate prevention of esophagitis, mucositis, xerostomia, radiation toxicity, and pneumonitis.
The Amifostine trials studied prevention of treatment-related toxicities. NCT00095927 examined Amifostine in squamous cell carcinoma of the head and neck, while NCT00081315 tested subcutaneous Amifostine for radiochemotherapy-induced esophagitis and pneumonitis in unresectable non-small cell lung cancer. Both were randomized, active-controlled Phase 2 studies conducted in the United States.