A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer

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

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