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Cisplatin-Epinephrine Injectable Gel Plus Paclitaxel and Carboplatin in Treating Patients With Recurrent Head and Neck Cancer
This study is ongoing, but not recruiting participants.
First Received: August 10, 2001   Last Updated: July 23, 2008   History of Changes
Sponsored by: Matrix Pharmaceutical
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022217
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: carboplatin
Drug: cisplatin-e therapeutic implant
Drug: paclitaxel
Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Salivary Gland Disorders
Drug Information available for: Epinephrine bitartrate Epinephrine Cisplatin Paclitaxel Carboplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022217

Locations
United States, Arizona
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, United States, 85012
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
United States, Illinois
Division of Head and Neck Surgery
Evanston, Illinois, United States, 60201
United States, Louisiana
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71130-3932
Sponsors and Collaborators
Matrix Pharmaceutical
Investigators
Study Chair: Laurence Elias, MD Matrix Pharmaceutical
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068796, MP-601-00-2, ENH-EH01-102
Study First Received: August 10, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00022217     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Neurotransmitter Agents
Adrenergic Agents
Laryngeal Carcinoma
Squamous Cell Carcinoma
Adrenergic Agonists
Hypopharyngeal Cancer
Anti-Bacterial Agents
Cisplatin
Vasoconstrictor Agents
Neoplasms, Squamous Cell
Epinephrine
Salivary Gland Diseases
Nasopharyngeal Carcinoma
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Carcinoma, Squamous Cell of Head and Neck
Anti-Asthmatic Agents
Antimitotic Agents
Carboplatin
Cardiovascular Agents
Epirubicin
Recurrence
Carcinoma
Mydriatics
Radiation-Sensitizing Agents
Paclitaxel
Head and Neck Neoplasms
Tubulin Modulators
Epidermoid Carcinoma
Peripheral Nervous System Agents

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Adrenergic Agonists
Neoplasms by Site
Cisplatin
Therapeutic Uses
Vasoconstrictor Agents
Neoplasms, Squamous Cell
Epinephrine
Neoplasms by Histologic Type
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Sympathomimetics
Mitosis Modulators
Anti-Asthmatic Agents
Antimitotic Agents
Carboplatin
Cardiovascular Agents
Epirubicin
Pharmacologic Actions
Carcinoma
Neoplasms
Mydriatics
Radiation-Sensitizing Agents
Paclitaxel

ClinicalTrials.gov processed this record on May 06, 2009