Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT01316757
Eligibility Criteria:
Criteria:
* Histologically confirmed squamous cell carcinoma of the head and neck that is metastatic or recurrent
* No prior systemic therapy for metastatic/recurrent disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Prior chemotherapy in the induction, organ preservation or adjuvant setting is permitted if it was completed more than 4 months prior to enrollment on the current study
* Prior cetuximab is permitted if it was given for no more than 9 doses in combination with radiation therapy or chemoradiation therapy for initial treatment of locally advanced disease
* No prior erlotinib, gefitinib or lapatinib therapy is permitted; nor is prior exposure to any investigational EGFR or panErbB reversible or irreversible inhibitor or any prior panitumumab or investigational EGFR-directed monoclonal antibody permitted
* Hemoglobin \> 9.0 G/dl
* Absolute neutrophil count (ANC) \> 1500 cells/mcl
* Creatinine (Cr) \< 1.8
* Total bilirubin =\< the institution's upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine transaminase (ALT) \< 2 X ULN
* No chronic active viral infection
* No other malignancy within 3 years
* No chronic diarrheal condition
* Females should not be pregnant or breast feeding because chemotherapy may be harmful to the fetus or the nursing infant; also, the effects of erlotinib and cetuximab on the developing human fetus are unknown
* All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy
* Women of childbearing potential and sexually active males must use an accepted and effective method of contraception while on treatment and for three months after the completion of treatment
* Patients must have measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST); baseline measurements and evaluations must be obtained within \< 4 weeks of randomization; all areas of disease should be recorded and mapped out in order to assess response and uniformity of response to therapy; disease in previously irradiated sites is considered measurable if there has been unequivocal disease progression or biopsy-proven residual carcinoma following radiation therapy; persistent disease without clear-cut progression after radiotherapy can be considered measurable if biopsy-proven at least 8 weeks after completion of radiation therapy
* Patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated; patients with a history of other prior malignancy must have been treated with curative intent and must have remained disease-free for 3 years post diagnosis
* No current peripheral neuropathy \> grade 2 at time of randomization
* Patients must not have any co-existing condition that would preclude full compliance with the study
* Human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with erlotinib
* Patients must have no history of allergic reaction to murine proteins
* Ability to understand and the willingness to sign a written informed consent
* Patients must not be receiving other investigational anti-cancer therapy
* Patients with brain metastases are not eligible
* Both men and women and members of all races and ethnic groups are eligible for this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01316757
Study Brief:
Protocol Section:
NCT01316757