A Study of Pemetrexed in Recurrent Cervical Adenocarcinomas
Condition: Adenocarcinoma of the Cervix; Adenosquamous Cell Carcinoma of the Cervix
MeSH terms: Adenocarcinoma; Carcinoma, Adenosquamous
Intervention: Pemetrexed
Intervention description: Pemetrexed 500 mg/m2
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients with advanced or recurrent adenocarcinoma or adenosquamous cell carcinoma of the
      cervix will receive Pemetrexed.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have had advanced or recurrent adenocarcinoma or adenosquamous cell
             carcinoma of the cervix with documented disease progression

          2. Patients must have had measurable disease defined as at least one lesion that could be
             accurately measured in at least one dimension, which must have been 20 mm when
             measured by conventional techniques including palpation, plain X-ray, computerized
             tomography (CT), and magnetic resonance imaging(MRI) or 10 mm when measured by spiral
             CT

          3. 18 years of age or older

          4. Eastern Cooperative Oncology Group (ECOG) performance status score < 2 and a life
             expectancy >3 months

          5. Life expectancy ≥ 12 weeks

          6. Participants must have measureable disease by RECIST criteria

          7. Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5
             g/dL

          8. Creatinine clearance ≥ 45 mL/min using the standard Cockcroft and Gault formula
             (below) or glomerular filtration rate (GFR) measured by
             Tc99m-diethylenetriaminepentacetate (DPTA) serum clearance method:

               1. Males: [140 - Age in years] × Actual Body Weight (kg) 72 × Serum Creatinine
                  (mg/dL)

               2. Females: Estimated creatinine clearance for males × 0.85

          9. Total bilirubin ≤ 2 mg/dL, aspartate transaminase (AST) and alanine transaminase (ALT)
             AST/ALT ≤ 5 times the upper limit of normal range

         10. At least 21 days from administration of chemotherapy

         11. No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to
             be clinically insignificant by the Principal Investigator

         12. At least four (4) weeks from prior major surgery

         13. Willingness to provide permission to access archived tumor samples and additional
             blood samples for evaluation of Foundation One Analysis where available Enterprise
             wide.

         14. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically
             sterile) must be willing to use an acceptable contraceptive method (abstinence, oral
             contraceptive or double barrier method) for the duration of the study and for 30 days
             following the last dose of study drug, and must have a negative urine or serum
             pregnancy test within 2 weeks prior to beginning treatment on this trial.

        Exclusion Criteria:

          1. Uncontrolled cardiac disease, congestive heart failure, angina, arrhythmias or
             hypertension.

          2. Myocardial infarction or unstable angina within 2 months of treatment.

          3. Known human immunodeficiency virus (HIV) infection or chronic active Hepatitis B or C
             (patients are NOT required to be tested for the presence of such viruses prior to
             therapy on this protocol).

          4. Active clinically serious infection > CTCAE (version 4.03) Grade 2.

          5. Thrombotic or embolic events such as a cerebrovascular accident including transient
             ischemic attacks within the past 6 months.

          6. Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of
             study drug.

          7. Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of
             study drug.

          8. Serious non-healing wound, ulcer, or bone fracture.

          9. Major surgery, open biopsy or significant traumatic injury within 4 weeks of first
             study drug.

         10. Inability to complete informed consent process and adhere to the protocol treatment
             plan and follow-up requirements.

         11. Concurrent severe illness such as active infection, or psychiatric illness/social
             situations that would limit safety and compliance with study requirements.