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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT01016769
Eligibility Criteria:
Inclusion Criteria:
* Patients must have microscopically confirmed head and neck squamous cell carcinoma (HNSCC), recurrent and/or metastatic.
* Confirmation of HNSCC may be obtained from the primary site or metastatic disease.
* Patients must be at least 18 years of age.
* Karnofsky Performance status must be ≥ 70%.
* Disease must be measurable by RECIST criteria.
* At least 6 weeks must have elapsed from previous radiation therapy. Patient must have recovered from the acute toxic effects of treatment prior to study enrollment.
* Adequate organ function, as follows:
* Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 109/L, platelets ≥ 100 X 109/L, and hemoglobin ≥ 9 g/dL.
* Hepatic: total bilirubin within normal limits (≤ 1.0 mg/dL); alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 X ULN (upper limit of normal)
* Renal: Serum creatinine ≤ 1.3 mg/dL. Patients with serum creatinine \> 1.3 mg/dL may be eligible if creatinine clearance (CrCl) ≥ 45 mL/min based on the standard Cockroft and Gault formula.
* Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
* Patients must sign an informed consent document.
Exclusion Criteria:
* Previous exposure to temsirolimus or other mTOR inhibitors
* More than 2 prior cytotoxic regimens in the recurrent/metastatic disease setting
* History of any brain metastases
* Patients who require concomitant medications that are metabolized by hepatic CYP3A4, due to potential drug-drug interaction with temsirolimus
* Patients with known active interstitial pneumonitis
* Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment.
* Women who are pregnant or lactating
* Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis
* Diagnosis of Nasopharyngeal cancer is excluded.
* Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living)
* Therapeutic anticoagulation with Coumadin (warfarin)
* Hypertriglyceridemia ≥ grade 2 (CTCAE version 3.0).
* Impaired lung function: O2 saturation 88% or less at rest on room air by Pulse Oximetry. If O2 saturation is ≤ 88% at rest, further pulmonary function tests (PFTs) should be ordered to confirm normal pulmonary function and eligibility.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01016769
Study Brief:
Protocol Section:
NCT01016769