A Phase II Study of Pemetrexed Plus Gemcitabine for Metastatic/Recurrent Head and Neck Cancer (HNSCC)
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Pemetrexed plus Gemcitabine
Intervention description: Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle. Vitamin supplementation will be as follows: Vitamin B12: 1000 µg IM injection no less than 1 week prior to the first dose of pemetrexed, and continuing approximately every 9 weeks until 3 weeks after the last dose of pemetrexed.
Folic acid: The preferred oral daily dose of folic acid is 350 to 1000 µg. Daily folate supplementation begins no less than 1 week prior to the first dose of pemetrexed and continues until 3 weeks after the last dose of pemetrexed.
For rash prophylaxis, dexamethasone (4 mg po twice per day) should be taken on the day before, the day of, and the day after each dose of pemetrexed unless clinical contraindications exist.
Intervention MeSH terms: Gemcitabine; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and Neck Cancer; GEMCITABINE; PEMETREXED; ALTIMA; epidermoid/squamous cell; carcinoma; pharynx; larynx; paranasal sinus; head/neck squamous cell carcinoma

Summary:

      The purpose of this study is to determine if the combination of 2 chemotherapy drugs called
      pemetrexed and gemcitabine might be effective treatment for head and neck squamous cell
      cancer. The researchers want to find out what effects, good and/or bad, that this treatment
      has on head and neck cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have microscopically confirmed epidermoid/squamous cell carcinoma
             (HNSCC) of the oral cavity, pharynx, larynx, paranasal sinus, or head/neck squamous
             cell carcinoma unknown primary.

          -  Patients must have recurrent or metastatic disease which is not amenable to
             curative-intent therapy with surgery or radiation.

          -  No more than 2 prior cytotoxic therapies in the recurrent or metastatic disease
             setting are permitted.

          -  Patients must be at least 18 years of age.

          -  Karnofsky Performance status must be ≥ 70%.

          -  Disease must be measurable by RECIST criteria.

          -  At least 4 weeks must have elapsed from previous radiation therapy. Patient must have
             recovered from the acute toxic effects of treatment prior to study enrollment.

          -  Prior radiation therapy to ≤ 25% of bone marrow is allowed. Prior radiation to the
             whole pelvis and/or brain is not allowed.

          -  Adequate organ function

          -  Patients of childbearing potential must have a negative test for pregnancy at time of
             enrollment based on a urine or serum pregnancy test. Patients must agree to use a
             reliable method of birth control during and for 3 months following the last dose of
             study drug.

          -  Patient must reside in geographic proximity to MSKCC for adequate follow-up during
             treatment, per investigator discretion.

          -  Patients must sign an informed consent document.

        Exclusion Criteria:

          -  Previous exposure to pemetrexed (Alimta) or gemcitabine (Gemzar).

          -  Pregnancy or breast-feeding.

          -  Serious concomitant systemic disorders (for example, active infection) that, in the
             opinion of the investigator, would compromise the safety of the patient or compromise
             the patient's ability to complete the study.

          -  History of any brain metastases.

          -  Inability or unwillingness to take folic acid, vitamin B12 supplementation, or
             dexamethasone.

          -  Patients will be excluded if they will be unable to hold use of nonsteroidal
             antiinflammatory agents (NSAIDS) with short elimination half lives