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| Sponsored by: |
University of Illinois |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003251 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Drug/Agent Toxicity by Tissue/Organ Head and Neck Cancer Radiation Toxicity |
Drug: amifostine trihydrate Drug: cisplatin Drug: paclitaxel Radiation: radiation therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care |
| Official Title: | A Pilot Study of Amifostine and Concomitant Cisplatin, Paclitaxel and Radiotherapy in Previously Irradiated, Recurrent Head and Neck Cancer |
| Estimated Enrollment: | 46 |
| Study Start Date: | December 1997 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000066133, UIC-H-97-783, ALZA-UIC-H-97-783, NCI-V98-1389 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003251 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
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Radiation-Protective Agents Nasopharyngeal Carcinoma Amifostine Laryngeal Carcinoma Laryngeal Neoplasms Antimitotic Agents Squamous Cell Carcinoma Recurrence Carcinoma Oral Cancer Hypopharyngeal Cancer |
Lip and Oral Cavity Cancer Radiation-Sensitizing Agents Cisplatin Paclitaxel Head and Neck Neoplasms Tubulin Modulators Epidermoid Carcinoma Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic Salivary Gland Diseases |
|
Radiation-Protective Agents Molecular Mechanisms of Pharmacological Action Amifostine Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Protective Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Cisplatin Radiation-Sensitizing Agents Paclitaxel Head and Neck Neoplasms Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |
