Amifostine Plus Chemotherapy and Radiation Therapy in Treating Patients With Advanced, Unresectable Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00003251|
Recruitment Status : Unknown
Verified June 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 13, 2004
Last Update Posted : December 4, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy and radiation therapy.
PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus cisplatin, paclitaxel, and radiation therapy in treating patients who have advanced unresectable head and neck cancer.
|Condition or disease||Intervention/treatment||Phase|
|Drug/Agent Toxicity by Tissue/Organ Head and Neck Cancer Radiation Toxicity||Drug: amifostine trihydrate Drug: cisplatin Drug: paclitaxel Radiation: radiation therapy||Phase 1 Phase 2|
OBJECTIVES: I. Assess the efficacy and role of amifostine as a cytoprotection agent with concurrent chemoradiotherapy in advanced, previously irradiated or metastatic head and neck cancer. II. Determine the toxicity and response to cisplatin, paclitaxel and radiation therapy in these patients. III. Determine the toxicity of amifostine in these patients.
OUTLINE: This is an open label study. Patients receive paclitaxel by continuous infusion on days 0-3. Amifostine IV is administered over 5 minutes on days 1-5. Radiation therapy is administered once daily on days 1-5. Cisplatin IV is administered on day 5. Patients receive no treatment on days 6-13. Treatment is repeated every 2 weeks for up to 7 courses in the absence of disease progression and unacceptable toxicity. Patients are followed monthly during the first year, every 2 months during the second year, then every 3 months thereafter.
PROJECTED ACCRUAL: This study will accrue 16-46 patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||A Pilot Study of Amifostine and Concomitant Cisplatin, Paclitaxel and Radiotherapy in Previously Irradiated, Recurrent Head and Neck Cancer|
|Study Start Date :||December 1997|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003251
|United States, Illinois|
|University of Illinois at Chicago Health Sciences Center|
|Chicago, Illinois, United States, 60612|
|Study Chair:||Fred R. Rosen, MD||University of Illinois at Chicago|