search
Back to results

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

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
cisplatin-e therapeutic implant
paclitaxel
Sponsored by
Matrix Pharmaceutical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veterans Affairs Medical Center - Phoenix (Hayden)
  • Veterans Affairs Medical Center - Tucson
  • Division of Head and Neck Surgery
  • Louisiana State University Health Sciences Center - Shreveport

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 10, 2001
Last Updated
December 17, 2013
Sponsor
Matrix Pharmaceutical
search

1. Study Identification

Unique Protocol Identification Number
NCT00022217
Brief Title
Cisplatin-Epinephrine Injectable Gel Plus Paclitaxel and Carboplatin in Treating Patients With Recurrent Head and Neck Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2002
Overall Recruitment Status
Unknown status
Study Start Date
November 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Matrix Pharmaceutical

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin-e therapeutic implant
Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Elias, MD
Organizational Affiliation
Matrix Pharmaceutical
Official's Role
Study Chair
Facility Information:
Facility Name
Veterans Affairs Medical Center - Phoenix (Hayden)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Veterans Affairs Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Division of Head and Neck Surgery
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs