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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

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


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.

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.

Inclusion 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

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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Laurence Elias, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Matrix Pharmaceutical

Authority:

United States: Federal Government

Study ID:

CDR0000068796

NCT ID:

NCT00022217

Start Date:

November 2000

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent salivary gland cancer
  • salivary gland squamous cell carcinoma
  • salivary gland anaplastic carcinoma
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • recurrent verrucous carcinoma of the oral cavity
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent lymphoepithelioma of the oropharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent lymphoepithelioma of the nasopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent verrucous carcinoma of the larynx
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Division of Head and Neck SurgeryEvanston, Illinois  60201