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

NCT00022217 | Unknown Phase 2

• 3 other identifiers: CDR0000068796MP-601-00-2ENH-EH01-102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

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

Interventions

carboplatin DRUG

cisplatin-e therapeutic implant DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Matrix Pharmaceutical: lead

Study Sites (4)

Veterans Affairs Medical Center - Phoenix (Hayden)

Phoenix, Arizona, 85012, United States

Location

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, 85723, United States

Location

Division of Head and Neck Surgery

Evanston, Illinois, 60201, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Salivary Gland Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Laurence Elias, MD

  Matrix Pharmaceutical

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: February 27, 2004
• Study Start: November 1, 2000
• Last Updated: December 18, 2013

Record last verified: 2002-02

Locations

US (4)