Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Intervention: cisplatin; pemetrexed disodium
Intervention description: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: Female
Maximum age: 120 Years
Healthy volunteers: No
Keywords: cervical squamous cell carcinoma; recurrent cervical cancer; stage III cervical cancer; stage IVA cervical cancer; stage IVB cervical cancer

Summary:

      RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways
      to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving pemetrexed together with cisplatin may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects of giving pemetrexed together with
      cisplatin and to see how well it works in treating patients with advanced, persistent, or
      recurrent cervical cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed squamous or nonsquamous cell carcinoma of the cervix

               -  Advanced, persistent, or recurrent disease

          -  Disease not amenable to curative therapy

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques or ≥ 10 mm by spiral CT scan

          -  Must have ≥ 1 target lesion to be used to assess response

               -  Tumors within a previously irradiated field will be designated as "non-target"
                  lesions unless progression is documented or a biopsy is obtained to confirm
                  persistence ≥ 90 days following completion of radiotherapy

        PATIENT CHARACTERISTICS:

          -  GOG performance status 0-2

          -  Platelet count ≥ 100,000/mm^3

          -  ANC ≥ 1,500/mm^3

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Creatinine clearance ≥ 60 mL/min

          -  SGOT ≤ 2.5 times ULN (≤ 5 times ULN if due to hepatic metastases)

          -  Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if due to hepatic metastases)

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Neuropathy (sensory and motor) ≤ grade 1

          -  Able to take folic acid, vitamin B12, and dexamethasone according to study protocol

          -  No history of other invasive malignancies within the past 5 years, except nonmelanoma
             skin cancer

          -  No active infection requiring antibiotics with the exception of uncomplicated UTI

          -  No presence of third space fluid which cannot be controlled by drainage

        PRIOR CONCURRENT THERAPY:

          -  Recovered from effects of recent surgery, radiotherapy, or other therapy

          -  At least 1 week since prior hormonal therapy directed at the malignant tumor

          -  At least 4 weeks since prior radiotherapy

          -  More than 3 years since prior radiotherapy for localized cancer of the breast, head
             and neck, or skin and patient remains free of recurrent or metastatic disease

          -  No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the
             treatment of cervical cancer

          -  No prior radiotherapy to more than 25% of marrow-bearing areas

          -  No prior cancer treatment that contraindicates study treatment

          -  No prior cytotoxic drugs for advanced or recurrent carcinoma of the cervix

               -  Prior cisplatin as a radiosensitizer for primary treatment of disease allowed

          -  No nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates 2-5 days before,
             during, or for 2 days after receiving pemetrexed disodium

               -  No NSAIDS with a long half-life (e.g., naproxen, piroxicam, diflunisal, or
                  nabumetone) 5 days before, during, and for 2 days after receiving pemetrexed
                  disodium

          -  Concurrent hormone replacement therapy is permitted

          -  Concurrent daily low-dose acetylsalicylic acid therapy (≤ 325 mg/day) allowed

          -  Concurrent use of acetylsalicylic acid (up to 1.3 g/day) allowed