Status:
TERMINATED
Erlotinib Hydrochloride and Radiation Therapy in Stage III-IV Squamous Cell Cancer of the Head and Neck
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage III Squamous Cell Carcinoma of the Hypopharynx
Stage III Squamous Cell Carcinoma of the Larynx
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib hydrochloride may also make tumor cells more sensitive to radiat...
Detailed Description
PRIMARY OBJECTIVES:I. To determine the time to progression of the combination of the EGFR inhibitor erlotinib and radiation therapy. SECONDARY OBJECTIVES:I. To determine objective response rate, locor...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed locally advanced (stage III or IV) squamous cell carcinoma of the head and neck without distant metastatic disease, who are not candidates or have declined definitive surgical resection or for administration of standard chemotherapy during radiation therapy because of any of the following reasons: advanced age (\>= 70 years); poor ECOG performance status (2 or 3); significant comorbidities, as reflected by a Charlson comorbidity index score of \>= 3; abnormal hematopoietic, hepatic or renal function; patient's decision after applicable standard treatment options have been offered and declined by patient
- No prior chemotherapy, radiation therapy, or investigational antitumor drug
- Measurable disease within 4 weeks prior to registration according to the recommended RECIST response criteria
- Life expectancy of greater than 12 weeks
- Patients must have normal hepatic function or well compensated liver disease as defined by the Child-Pugh classification of severity of liver disease; patients with hepatic impairment (total bilirubin greater than upper limit of normal \[ULN\] or well-compensated disease \[Child-Pugh class A\] enrolled in the trial will be closely monitored, especially those with total bilirubin \> 3 times ULN; dosage modifications (therapy interruption or discontinuation) may be necessary for severe changes in liver function; patient management will follow the FDA-approved labeling recommendations
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
- Women of childbearing potential must have a negative pregnancy test; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and willingness to sign a written informed consent document
Exclusion
- All histologies other than squamous cell carcinoma
- Salivary gland paranasal sinus and nasopharyngeal squamous cell carcinoma
- Patients who have had prior chemotherapy or radiotherapy
- Patients with metastatic disease
- Patients with ECOG performance status of 4
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ERLOTINIB
- Patients with history of any other malignancy (except squamous cell or basal cell cancer of the skin or CIS of cervix) are ineligible unless a period of 5 years has elapsed since treatment of the previous cancer and the patient is currently disease-free from the previous cancer
- Patients may not be receiving any other investigational agent
- Pregnant women; breastfeeding should be discontinued
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01192815
Start Date
January 1 2011
End Date
October 1 2012
Last Update
May 12 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106