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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT00425750
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
* Recurrent or metastatic disease
* Measurable disease
* Not a candidate for curative therapy
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm³
* Hemoglobin ≥ 8.0 g/dL
* Platelet count ≥ 100,000/mm³
* AST, ALT, and alkaline phosphatase (AP) meeting 1 of the following criteria:
* AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
* AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
* AP ≤ 5 times ULN AND AST and ALT normal
* Bilirubin normal
* Creatinine clearance ≤ 2.0 mg/dL
* No peripheral neuropathy ≥ grade 2 within the past 28 days
* No myocardial infarction within the past 6 months
* No New York Heart Association class III or IV heart failure
* No uncontrolled angina
* No severe uncontrolled ventricular arrhythmias
* No electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* No known hypersensitivity to bortezomib, boron, or mannitol
* No known severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* No serious medical or psychiatric illness that would preclude study participation
* No other malignancy within the past 3 years except for early-stage nonmelanomatous skin cancer, carcinoma in situ of the cervix, or early-stage prostate cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy for recurrent or metastatic disease
* At least 28 days since prior and no other concurrent investigational drugs
* No other concurrent anticancer therapy
* No other concurrent chemotherapy
* No concurrent complementary or herbal medicine
* No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00425750
Study Brief:
Protocol Section:
NCT00425750