RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug and giving the drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of cisplatin - epinephrine injectable gel plus paclitaxel and carboplatin in treating patients who have recurrent head and neck cancer.

Condition	Treatment or Intervention	Phase
Nose Cancer Oral Cancer Throat Cancer	Drug: carboplatin  Drug: cisplatin-epinephrine  Drug: paclitaxel	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the antitumor activity of intratumoral cisplatin-epinephrine injectable gel and systemic paclitaxel and carboplatin in patients with recurrent squamous cell carcinoma of the head and neck. II. Determine the safety of this regimen in this patient population. III. Determine the time to progression, pattern of progression, and rate of relapse of patients treated with this regimen. VI. Determine the time to response and duration of response of patients treated with this regimen. V. Determine the overall survival of patients treated with this regimen.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive cisplatin-epinephrine gel intratumorally on days -15, -8, 1, 8, 15, and 22 for course 1 and days 1, 8, 15, and 22 for all subsequent courses. Patients also receive paclitaxel IV over at least 3 hours followed by carboplatin IV over at least 30 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve local complete response (CR) and no metastatic disease progression continue treatment with carboplatin and paclitaxel only. Patients who achieve total CR may receive 2 additional courses of carboplatin and paclitaxel. Patients are followed at 1-4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed recurrent primary squamous cell carcinoma of the head and neck
• The following other histological types are also eligible: Epithelial carcinoma; Verrucous carcinoma; Sarcomatoid squamous cell carcinoma; Lymphoepithelioma; Pseudosarcoma; Anaplastic carcinoma; Transitional cell carcinoma
• At first relapse after prior definitive surgery, radiotherapy, and/or chemotherapy and not a candidate for potentially curative salvage surgery or salvage radiotherapy
• Relapsed or metastatic disease in one of the following primary head and neck areas or other metastatic sites of skin or soft tissue accessible for local injection: Oral cavity (including tongue, floor of mouth, uvula, and tonsil); Hypopharynx; Larynx; Nasopharynx; Paranasal sinus; Salivary gland
• Tridimensionally measurable disease; Tumor no greater than 20 cm3; At no immediate risk of invasion of a major vessel of the extracranial vascular system (e.g., the common, internal, or external carotid artery or the vertebral artery); Amenable to direct injection by physical exam, ultrasound, or CT guidance
• Visceral metastases (e.g., lung) allowed but not eligible for injection with cisplatin-epinephrine gel

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: See Disease Characteristics; At least 28 days since prior chemotherapy and recovered; Prior carboplatin or taxanes allowed, but not in combination
• Endocrine therapy: Concurrent stable-dose prednisone/prednisolone for chronic disease allowed; Concurrent stable-dose corticosteroid inhalants for asthma prophylaxis allowed; Concurrent dexamethasone as an antiemetic allowed
• Radiotherapy: See Disease Characteristics; At least 28 days since prior radiotherapy and recovered; Concurrent limited-field radiotherapy for symptomatic metastatic disease not amenable to cisplatin-epinephrine gel allowed
• Surgery: See Disease Characteristics; At least 28 days since prior surgery and recovered
• Other: No concurrent anesthetics or topical preparations containing epinephrine; No other concurrent cancer therapy; No drugs that interact with cisplatin (e.g., probenecid or thiazide) during and for 28 days after study

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: At least 3 months
• Hematopoietic: Platelet count at least 100,000/mm3; Neutrophil count at least 1,500/mm3; Hemoglobin at least 10 g/dL
• Hepatic: Bilirubin less than 3 mg/dL AST no greater than 3 times upper limit of normal (ULN); Alkaline phosphatase no greater than 3 times ULN; Albumin no greater than 2.5 g/dL; PT within 3 seconds of normal
• Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 50 mL/min
• Cardiovascular: See Disease Characteristics; No New York Heart Association class III or IV heart disease
• Other: No other malignancy within the past 5 years except nonmelanoma skin cancer outside the area of planned cisplatin-epinephrine gel treatment; No known hypersensitivity to cisplatin, carboplatin, paclitaxel, bovine collagen, epinephrine, or sulfites; No infection requiring parenteral antibiotics; No medical or psychiatric condition that would preclude informed consent; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

Arizona
      Veterans Affairs Medical Center - Phoenix (Hayden), Phoenix,  Arizona,  85012,  United States
      Veterans Affairs Medical Center - Tucson, Tucson,  Arizona,  85723,  United States
Illinois
      Division of Head and Neck Surgery, Evanston,  Illinois,  60201,  United States
Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States

Study chairs or principal investigators

Laurence Elias,  Study Chair,  Matrix Pharmaceutical   

Study ID Numbers:  CDR0000068796; MP-601-00-2; ENH-EH01-102
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022217
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08