Phase 2 Study of Pemetrexed in Combination With Cisplatin and Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- Histologically confirmed diagnosis of squamous cell carcinoma of head and neck
- Recurrent or metastatic SCCHN, not amenable to local therapy
- At least 6 months since completion of systemic therapy (chemotherapy or biological
- 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
- An estimated life expectancy of at least 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Oken et al.
- 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.
- 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
- 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
- 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