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:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT00617734
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically-confirmed squamous cell carcinoma of the oropharynx, hypopharynx, larynx, or oral cavity, metastasis or recurrence documented by clinical imaging studies
* Measurable disease, lesion size ≥ 2 centimeters (cm) on conventional measurement techniques or ≥ 1 cm on spiral computed tomography (CT) scan
* Clinical documentation of disease progression during treatment with or within 90 days after receiving the last cycle of platinum-based chemotherapy (with or without radiation therapy)
* If prior treatment with anti-epidermal growth factor receptor (EGFR) therapy, the time to recurrence from last exposure to anti-EGFR therapy is \> 90 days
* Adequate hematologic function
* Adequate hepatic function
* Adequate coagulation function or is on a stable dose of an anticoagulant.
* Adequate renal function
* Fasting serum glucose \<120 milligrams per deciliter (mg/dL) or below the upper limit of normal (ULN)
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion Criteria:
* Not recovered from adverse events due to agents administered more than 4 weeks earlier. Neurotoxicity, must have recovered to grade ≤ 2
* Is receiving any other investigational agent(s)
* History of treatment with other agents targeting the insulin-like growth factor receptor (IGFR)
* Is receiving concurrent treatment with other anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy
* History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab or IMC-A12
* Has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range (fasting \< 120 mg/dL or below ULN) and that they are on a stable dietary or therapeutic regimen for this condition
* Pregnant or breastfeeding
* Is receiving therapy with immunosuppressive agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00617734
Study Brief:
Protocol Section:
NCT00617734