Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: pemetrexed; gemcitabine
Intervention description: pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle; gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
Intervention MeSH terms: Gemcitabine; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: advanced; head; neck; cancer

Summary:

      The purpose of this study is to look at how well the combination of two chemotherapy drugs,
      pemetrexed (Alimta) and gemcitabine (Gemzar) work to treat your cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of squamous cell cancer of the head and neck - unresectable or metastatic.
             Must have measurable disease by RECIST.

          -  Karnofsky performance status greater than or equal to 60%

          -  Up to one prior systemic chemotherapy, immunotherapy allowed in the advanced or
             metastatic setting. This does not include prior chemotherapy, immunotherapy used with
             radiotherapy (ie concurrent with radiation therapy or as and induction regimen pror to
             definitive radiation therapy).

          -  At least 4 weeks from prior radiation or chemotherapy, must have recovered from all
             acute effects of treatment.

          -  Adequate organ and marrow function

          -  Negative pregnancy test. Agree to use birth control during and for 3 months after last
             dose of study drug.

          -  At least 18 years of age.

          -  Sign an informed consent and HIPAA consent.

          -  Must be able to take and absorb enteral medication.

        Exclusion Criteria:

          -  Serious concomitant systemic disorder that would compromise safety or ability to
             complete study.

          -  Prior treatment with gemcitabine or pemetrexed within the previous year, unless used
             concurrently with radiation therapy.

          -  Pregnancy or breastfeeding.

          -  Symptomatic or uncontrolled brain mets. If treated, must be off steroids for at least
             2 weeks.

          -  Inability or unwilling to take folic acid, vitamin B12, or dexamethasone.

          -  Treatment within last 30 days with a drug that has not received regulatory approval
             for any indication.

          -  Inability to interrupt and NSAID or salicylate with a long half-life (piroxicam or
             nabumetone) for a 5 day period.

          -  Presence of clinically relevant third space fluid that cannot be controlled by
             drainage or other procedure prior to study entry.

          -  Active, concurrent, invasive malignancy requiring ongoing treatment.

          -  Corticosteroids impermissible unless for adrenal failure, septic shock or as
             temporizing measure for symptomatic pain, breathing, or rash.