Amifostine Plus Chemotherapy and Radiation Therapy in Treating Patients With Advanced, Unresectable Head and Neck Cancer
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| ClinicalTrials.gov Identifier: NCT00003251 |
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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
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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 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically documented metastatic or previously irradiated recurrent locoregional squamous cell or mucoepidermoid carcinoma of the head and neck Unresectable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100% Life expectancy: Greater than 4 months Hematopoietic: WBC at least 3000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1500/mm3 Hepatic: Bilirubin no greater than 2.5 times normal SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Other: No other significant infection No other medical or psychiatric illness Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 month since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 months since prior radiotherapy (patients with recurrent disease) to head and neck region Surgery: Not speciified Other: At least 24 hours since antihypertensive medication
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 |
| ClinicalTrials.gov Identifier: | NCT00003251 History of Changes |
| Other Study ID Numbers: |
CDR0000066133 UIC-H-97-783 ALZA-UIC-H-97-783 NCI-V98-1389 |
| First Posted: | August 13, 2004 Key Record Dates |
| Last Update Posted: | December 4, 2013 |
| Last Verified: | June 2000 |
Keywords provided by National Cancer Institute (NCI):
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stage III nasopharyngeal cancer stage IV nasopharyngeal cancer recurrent nasopharyngeal cancer stage III salivary gland cancer stage IV salivary gland cancer recurrent salivary gland cancer salivary gland squamous cell carcinoma high-grade salivary gland mucoepidermoid carcinoma stage III lip and oral cavity cancer stage IV lip and oral cavity cancer recurrent lip and oral cavity cancer stage III hypopharyngeal cancer stage IV hypopharyngeal cancer recurrent hypopharyngeal cancer stage III laryngeal cancer |
stage IV laryngeal cancer recurrent laryngeal cancer stage III paranasal sinus and nasal cavity cancer stage IV paranasal sinus and nasal cavity cancer recurrent paranasal sinus and nasal cavity cancer stage III oropharyngeal cancer stage IV oropharyngeal cancer recurrent oropharyngeal cancer stage III squamous cell carcinoma of the lip and oral cavity stage III mucoepidermoid carcinoma of the oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage IV mucoepidermoid carcinoma of the oral cavity recurrent squamous cell carcinoma of the lip and oral cavity recurrent mucoepidermoid carcinoma of the oral cavity stage III squamous cell carcinoma of the oropharynx |
Additional relevant MeSH terms:
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Head and Neck Neoplasms Radiation Injuries Neoplasms by Site Neoplasms Wounds and Injuries Paclitaxel Albumin-Bound Paclitaxel Cisplatin Amifostine |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Radiation-Protective Agents Protective Agents Physiological Effects of Drugs |