A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Intervention: Pemetrexed; Cetuximab; Carboplatin; Cisplatin
Intervention description: Administered intravenously, for maximum of 6 cycles.; Administered intravenously in combination therapy, for a maximum of 6 cycles.
After the completion of 6 cycles, participants who have not experienced disease progression will continue on cetuximab monotherapy until disease progression.; Administered intravenously, for a maximum of 6 cycles; Administered intravenously, for a maximum of 6 cycles
Intervention MeSH terms: Carboplatin; Pemetrexed; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pharynx; Larynx; Nose; Parathyroid

Summary:

      The purpose of this study is to look for an improvement in progression free survival with the
      combination of pemetrexed, carboplatin (or cisplatin) and cetuximab in participants with
      recurrent or metastatic squamous cell carcinoma of the head and neck.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic diagnosis of squamous cell head and neck cancer (HNC)

               -  Recurrent disease (locally advanced or metastatic) that is not amenable to local
                  therapy, (i) with at least 6 months since completion of systemic therapy
                  (chemotherapy or biological anticancer therapy), and (ii) with no more than 1
                  prior multimodal therapy (such as concurrent chemoradiation with or without
                  sequential chemotherapy) for locally advanced HNC tumor, and (iii) with no prior
                  systemic therapy (chemotherapy or biological anticancer therapy) for metastatic
                  disease; OR

               -  Newly diagnosed distant metastatic disease (Stage IVc)

          -  Prior therapies:

               -  Radiation therapy must be completed at least 4 weeks before study enrollment. For
                  palliative therapy, prior radiation therapy allowed <25% of the bone marrow and
                  prior radiation to the whole pelvis is not allowed. Participants must have
                  recovered from the acute toxic effects of the treatment prior to study
                  enrollment.

               -  Surgery (excluding prior diagnostic biopsy) must be completed at least 4 weeks
                  before study enrollment. Participants must have fully recovered from any acute
                  effects of surgery prior to study enrollment.

          -  An estimated life expectancy of at least 12 weeks.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

          -  Biological tissue available for biomarker analysis on tumor tissue.

          -  Disease status must be measurable as defined by Response Evaluation Criteria in Solid
             Tumors (RECIST). The index lesion must not be in a prior irradiated area. Positron
             emission tomography (PET) scans and ultrasounds may not be used for lesion
             measurements.

          -  Participant compliance and geographic proximity that allow for adequate follow-up.

          -  Adequate organ function as defined by the following:

               -  Bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC)
                  greater than or equal to 1.5 × 10⁹/liter (L), platelets greater than or equal to
                  100 × 10⁹/L, and hemoglobin greater than or equal to 9 grams/deciliter (g/dL).

               -  Hepatic: bilirubin less than or equal to 1.5 × the upper limit of normal (ULN);
                  alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine
                  aminotransferase (ALT) less than or equal to 3.0 × ULN (ALP, AST, and ALT less
                  than or equal to 5.0 × ULN is acceptable if the liver has tumor involvement).

               -  Renal: calculated creatinine clearance (CrCl) greater than or equal to 45
                  milliliters/minute (mL/min).

          -  For women: Must be surgically sterile, postmenopausal, or compliant with a medically
             approved contraceptive regimen 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:

          -  Have received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry.

          -  Are receiving concurrent chronic systemic immune therapy, or chemotherapy for a
             disease other than cancer.

          -  Concurrent administration of any other antitumor therapy.

          -  Known prior allergic/hypersensitivity reaction to any of the components of the study
             treatment.

          -  Serious concomitant systemic disorder (for example, active infection) or psychiatric
             disorder that, in the opinion of the investigator, would compromise the participant's
             ability to complete the study.

          -  Have serious cardiac disease, such as symptomatic angina, 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 HNC, unless that prior malignancy was
             treated at least 2 years previously with no evidence of recurrence. Exception:
             Participants 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.

          -  Nasopharyngeal, paranasal sinus, lip, or salivary gland cancer.

          -  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 of Common Terminology Criteria for Adverse Events (CTCAE)
             Grade 1 or higher.

          -  Have central nervous system (CNS) metastases (unless the participant 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
             participants to rule out brain metastases, but is not required in asymptomatic
             participants.

          -  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.