a study for patients with recurrent or metastatic squamous cell head and neck cancer

Conditions: Head and Neck Neoplasms

Summary: the purpose of this trial is to estimate progression free survival in patients with recurrent or metastatic head and neck cancer that have not received chemotherapy in this setting.

a 12 patient safety lead will evaluate side effects in patients receiving at least 2 cycles of the combination pemetrexed, cisplatin and cetuximab.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of squamous cell carcinoma of head and neck (scchn) * recurrent or metastatic scchn, not amenable to local therapy * at least 6 months since completion of systemic therapy (chemotherapy or biological anticancer therapy) * no more than 1 prior systemic therapy, given as part of multimodal treatment for locally advanced disease; * no prior systemic therapy for metastatic disease * radiation therapy must be completed at least 4 weeks before study enrollment. * for palliative therapy, prior radiation therapy allowed to \<25% of the bone marrow (cristy and eckerman 1987), and prior radiation to the whole pelvis is not allowed. * surgery (excluding prior diagnostic biopsy) must be completed at least 4 weeks before study enrollment. * an estimated life expectancy of at least 12 weeks. * eastern cooperative oncology group (ecog) performance status 0 or 1 (oken et al. 1982). * biological tissue available for biomarker analysis on tumor tissue. * disease status may be measurable or nonmeasurable as defined by response evaluation criteria in solid tumors * patient compliance and geographic proximity that allow for adequate follow-up. * adequate organ function * willingness to comply with contraceptive regimen * for women: must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen \[for example, intrauterine device (iud), birth control pills, or barrier device\] during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrollment, and must not be breast-feeding. for men: must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period. exclusion criteria: * nasopharyngeal, paranasal sinus, lip, or salivary gland cancer. * previously received treatment with monoclonal antibody therapy, or other signal transduction inhibitors of epidermal growth factor receptor therapy. * are receiving concurrent chronic systemic immune therapy, or chemotherapy for a disease other than cancer. * serious concomitant systemic disorder (for example, active infection) or psychiatric disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study. * have serious cardiac disease, such as symptomatic , unstable angina, or the history of myocardial infarction in the previous 12 months. * second primary malignancy that is clinically detectable at the time of consideration for study enrollment. * have had another primary malignancy other than head and neck cancer, unless that prior malignancy was treated at least 2 years previously with no evidence of recurrence. exception: patients with a history of in situ carcinoma of the cervix, nonmelanoma skin cancer, or low-grade (gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed and treated less than 2 years previously. * presence of clinically significant (by physical exam) third-space fluid collections; for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry. * have peripheral neuropathy * have central nervous system (cns) metastases (unless the patient has completed successful local therapy for cns metastases and has been off corticosteroids for at least 4 weeks before starting study therapy). brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients. * inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam). * unable or unwilling to take folic acid, vitamin b12, or prophylactic corticosteroids. * recent (within 30 days before enrollment) or concurrent yellow fever vaccination. * pregnant or breast-feeding

Keywords: pharynx larynx cervical esophagus nose thyroid gland parathyroid gland