Clinical trial NCT01057589 (phase 2, status: completed)
Conditions: head and neck neoplasms
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: pemetrexed, cetuximab, cisplatin
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H], [H][C@]12SCC(COC(C)=O)=C(N1C(=O)[C@H]2NC(=O)C(=N/OC)\C1=CSC(N)=N1)C(O)=O, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
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