Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Cisplatin-Epinephrine Injectable Gel Plus Paclitaxel and Carboplatin in Treating Patients With Recurrent Head and Neck Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over Pharmaceutical / Industry MP-601-00-2 ENH-EH01-102, NCT00022217

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.

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

Expected Enrollment

Approximately 40 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Matrix Pharmaceutical, Incorporated

Laurence Elias, MD, Protocol chair(Contact information may not be current)		Ph: 510-494-7700

Registry Information
Official Title		A Phase II Activity And Safety Study Of IntraDose (Cisplatin/Epinephrine Injectable Gel) When Given In Combination With Systematic Chemotherapy Paclitaxel And Carboplatin In The Treatment Of Patients With Squamous Cell Carcinoma Of The Head And Neck At First Relapse
Trial Start Date		2000-11-07
Registered in ClinicalTrials.gov		NCT00022217
Date Submitted to PDQ		2001-06-11
Information Last Verified		2002-02-01