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Cisplatin and ZD1839 + Re-Irradiation in Recurrent Squamous Cell Cancer of the Head and Neck

Primary Purpose

Head and Neck Cancer, Carcinoma, Squamous Cell

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ZD-1839
Cisplatin
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

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

Inclusion Criteria:- Patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract or a second squamous cell primary (excluding nasopharynx or salivary gland tumors). Patients may have experienced more than one recurrence as long as the first recurrence occurred greater than or equal to 6 months following the end of the prior RT. The recurrence or second primary must have defined bi- or uni-dimensional measurements. Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence). The patient must not be a candidate for complete surgical resection. The previous irradiation must not exceed a maximum of 75 Gy. The entire tumor volume must be included in a treatment field that limits the total spinal cord dose to 50 Gy (prior RT and anticipated RT). Patients must be at least 6 months from prior radiation therapy. Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease. Zubrod performance status 0-1. Granulocytes greater than or equal to 1500/mm3, platelets greater than or equal to 100,000/mm3, serum bilirubin less than or equal to 1.5 mg/dl, creatinine less than or equal to 1.5 mg/dl within 2 weeks prior to registration. LFT's less than or equal to 2 x normal (SGOT/SGPT/Alkaline Phosphatase). If greater than 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible. Must be able to submit previous radiation records, including simulation and portal films, in order to assure that cord tolerance is not exceeded. Patients must sign a study-specific informed consent form prior to study entry. Exclusion Criteria:- Primary in the nasopharynx or the salivary gland. Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ZD1839 or other agents used in study. Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.

Sites / Locations

  • Stanford University School of Medicine

Outcomes

Primary Outcome Measures

To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD 1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck

Secondary Outcome Measures

To estimate the median and one-year disease-free and overall survival rates of the treated patients.
To determine the response rate, duration of response and duration of stable disease in these treated patients.
To identify and estimate the incidence rate of acute and late toxicities associated with combined ZD1839, chemotherapy and re-irradiation in patients with recurrent squamous cell cancer of the head and neck.
To determine the pattern of disease progression in recurrent disease patients treated with this regimen.
To assay EGFR pathway-related proteins by IHC and cDNA microarray, and to correlate their baseline expression, as well as changes in expression after therapy, with clinical endpoints including tumor remission and one-year survival.

Full Information

First Posted
September 12, 2005
Last Updated
March 25, 2010
Sponsor
Stanford University
Collaborators
American Society of Clinical Oncology, AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00185835
Brief Title
Cisplatin and ZD1839 + Re-Irradiation in Recurrent Squamous Cell Cancer of the Head and Neck
Official Title
Phase I Study of Cisplatin And ZD1839 (IRESSA®) in Combination With Concomitant Re-Irradiation in Patients With Loco-Regional Recurrent Squamous Cell Cancer of the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Stanford University
Collaborators
American Society of Clinical Oncology, AstraZeneca

4. Oversight

5. Study Description

Brief Summary
To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck. To study the effects of ZD1839 combined with either cisplatin or radiotherapy on signal transduction pathway gene expression in tumor cells in patients with local-regional recurrent squamous cell cancer of the head and neck using micro array analysis from tumor samples taken at the time of relapse and during treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Carcinoma, Squamous Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ZD-1839
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Primary Outcome Measure Information:
Title
To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD 1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck
Time Frame
no known
Secondary Outcome Measure Information:
Title
To estimate the median and one-year disease-free and overall survival rates of the treated patients.
Time Frame
one year
Title
To determine the response rate, duration of response and duration of stable disease in these treated patients.
Title
To identify and estimate the incidence rate of acute and late toxicities associated with combined ZD1839, chemotherapy and re-irradiation in patients with recurrent squamous cell cancer of the head and neck.
Time Frame
no known
Title
To determine the pattern of disease progression in recurrent disease patients treated with this regimen.
Title
To assay EGFR pathway-related proteins by IHC and cDNA microarray, and to correlate their baseline expression, as well as changes in expression after therapy, with clinical endpoints including tumor remission and one-year survival.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- Patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract or a second squamous cell primary (excluding nasopharynx or salivary gland tumors). Patients may have experienced more than one recurrence as long as the first recurrence occurred greater than or equal to 6 months following the end of the prior RT. The recurrence or second primary must have defined bi- or uni-dimensional measurements. Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence). The patient must not be a candidate for complete surgical resection. The previous irradiation must not exceed a maximum of 75 Gy. The entire tumor volume must be included in a treatment field that limits the total spinal cord dose to 50 Gy (prior RT and anticipated RT). Patients must be at least 6 months from prior radiation therapy. Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease. Zubrod performance status 0-1. Granulocytes greater than or equal to 1500/mm3, platelets greater than or equal to 100,000/mm3, serum bilirubin less than or equal to 1.5 mg/dl, creatinine less than or equal to 1.5 mg/dl within 2 weeks prior to registration. LFT's less than or equal to 2 x normal (SGOT/SGPT/Alkaline Phosphatase). If greater than 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible. Must be able to submit previous radiation records, including simulation and portal films, in order to assure that cord tolerance is not exceeded. Patients must sign a study-specific informed consent form prior to study entry. Exclusion Criteria:- Primary in the nasopharynx or the salivary gland. Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ZD1839 or other agents used in study. Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quynh-Thu Le
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cisplatin and ZD1839 + Re-Irradiation in Recurrent Squamous Cell Cancer of the Head and Neck

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