A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Intervention: Pemetrexed; Cetuximab; Cisplatin; Folic Acid; Vitamin B12
Intervention description: Triplet Combination Therapy: 500 mg/m^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles
Maintenance Therapy: 500mg/m^2 administered intravenously on Day 1 of 21 day cycle until disease progression or unacceptable toxicity; Triplet Combination Therapy: 400 mg/m^2 administered intravenously on Day 1 of 21 day cycle for 1 cycle; 250 mg/m^2 administered IV infusion on Day 1 of 21 day cycle and then weekly for up to 6 cycles.
Maintenance Therapy: 250 mg/m^2 administered intravenously on Day 1 of 21 day cycle and then weekly until disease progression or unacceptable toxicity; Triplet Combination Therapy: 75mg/m^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles.; Standard of care dietary supplements: 350 to 1000 µg orally 5 times a day for the 7 days preceding the first dose of first dose of pemetrexed and continuing throughout treatment and for 21 days after the last dose of pemetrexed.; Standard of care dietary supplements: 1000 µg IM during the week preceding the first dose of pemetrexed and every 9 weeks thereafter.
Intervention MeSH terms: Folic Acid; Vitamin B 12; Pemetrexed; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pharynx; Larynx; Cervical esophagus; Nose; Thyroid Gland; Parathyroid Gland

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.
    

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