Pemetrexed and Carboplatin in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Condition: Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
MeSH terms: Carcinoma; Fallopian Tube Neoplasms; Recurrence
Intervention: Carboplatin; Laboratory Biomarker Analysis; Pemetrexed Disodium
Intervention description: Given IV; Correlative studies; Given IV
Intervention MeSH terms: Carboplatin; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well pemetrexed disodium and carboplatin work in treating
      patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer. Drugs used in
      chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a histopathologically confirmed diagnosis of epithelial ovarian,
             primary peritoneal, or fallopian tube carcinoma

          -  Patients must have received at least 1 prior platinum and taxane based chemotherapy
             regimen; patients may have failed no more than 2 prior chemotherapy regimens

          -  Patients must have "platinum sensitive" disease, which will be defined as those
             patients with relapsed disease who had an initial complete remission, and relapsed
             more than 6 months after completion of initial platinum based chemotherapy

          -  Recurrent disease must be confirmed by:

               -  Bidimensionally measurable disease which can be measured by physical examination
                  or by means of medical imaging techniques (measurable disease)

                    -  Measurable disease is defined as at least one lesion that can be accurately
                       measured in at least one dimension (longest dimension to be recorded); each
                       lesion must be >= 2.0 cm when measured by conventional techniques, including
                       palpation, x-ray, computed tomography (CT), and magnetic resonance imaging
                       (MRI), or >= 1.0 cm when measured by spiral CT; all measurable lesions up to
                       a maximum of 5 lesions per organ and 10 lesions in total representative of
                       all involved organs should be identified as target lesions and will be
                       recorded and measured at baseline; all baseline evaluations of disease
                       status should be performed as close as possible to the start of treatment
                       and never more than 4 weeks before the beginning of treatment

                    -  Target lesions should be selected on the basis of their size (lesions with
                       the longest dimension, LD) and their suitability for accurate repetitive
                       measurements by one consistent method of assessment (either clinically or by
                       imaging techniques); a sum of LD for all target lesions will be calculated
                       and reported as the baseline sum LD; the baseline sum LD will be used as
                       reference to further characterize the objective tumor response of the
                       measurable dimension of the disease; all other lesions (or sites of disease)
                       should be identified as non-target lesions and should also be recorded at
                       baseline OR

               -  Two confirmed serum cancer antigen-125 (CA-125) levels greater than or equal to
                  70 u/ml (or 2 x upper limit of normal) separated by 1 week and obtained within 4
                  weeks prior to entry to the study (evaluable disease)

          -  Patients must not have had other myelosuppressive therapy within four weeks of
             initiating pemetrexed/ carboplatin therapy

          -  Patients must have recovered from effects of recent surgery

          -  Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

          -  White blood cell (WBC) greater than or equal to 3,000/ul

          -  Platelet count greater or equal to 100,000/ul

          -  Neutrophil count greater or equal to 1,500/ul

          -  Creatinine clearance >= 45 ml/min (estimated creatinine clearance by Cockcroft-Gault
             equation acceptable)

          -  Total bilirubin =< to 1.5 mg/dL

          -  Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate
             transaminase (SGPT) =< three times the upper normal institutional limits; if patient
             has known hepatic metastases, patients may be enrolled if liver function test is =<
             five times the upper normal institutional limits

          -  Alkaline phosphatase =< three times the upper normal institutional limits; if patient
             has known hepatic metastases, patients may be enrolled if liver function test is =<
             five times the upper normal institutional limits

          -  Patient must have signed informed consent

          -  Patients must be willing to take the dexamethasone, folic acid and vitamin B12
             supplementation as indicated in the protocol to reduce adverse drug toxicity

          -  Patients must be willing to interrupt aspirin and other nonsteroidal anti-inflammatory
             drugs (NSAID) intake for 2 days before, day of, and 2 days after each chemotherapy
             treatment; low dose 80 mg aspirin and cyclooxygenase-2 (Cox-2) inhibitors are excluded
             from this restriction; if concomitant administration of an NSAID is necessary,
             patients should be monitored closely

          -  Patients must have a life expectancy of greater than 12 weeks

          -  Patients may not have concurrent or previous invasive malignancies, with the exception
             of non-melanoma skin cancer or no evidence of recurrence of previous malignancy within
             the last 5 years

          -  Patients must have a current exam, blood work and any clinically indicated imaging
             studies within 4 weeks prior to study enrollment

          -  Baseline folate and homocysteine blood levels

          -  The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day
             of, and 2 days following administration of Alimta

          -  The ability to take folic acid, vitamin B12, and dexamethasone according to protocol

        Exclusion Criteria:

          -  Patients who have had more than two prior chemotherapeutic regimens

          -  Patients who have had prior treatment with pemetrexed

          -  Patients with a GOG performance status of 3 or 4

          -  Patients with >= grade 2 neuropathy

          -  Patients who have received external beam whole pelvic or whole abdominal radiation
             treatment (>= 4500 centigray [cGy]) which would limit vascular capacity and reduce
             adequate drug delivery

          -  Patients with evidence of recurrence from another malignancy within the previous five
             years

          -  Patients with a concomitant malignancy other than squamous cell skin cancer

          -  Patients with uncontrolled intercurrent illness including, but not limited to, ongoing
             or active infection, unstable angina pectoris, or psychiatric illness/social
             situations that would limit compliance with study requirements

          -  Patients who have received an investigational drug within the last 30 days that has
             not received regulatory approval

          -  Presence of third space fluid which cannot be controlled by drainage; for patients who
             develop or have baseline clinically significant pleural or peritoneal effusions (on
             the basis of symptoms or clinical examination) before or during initiation of Alimta
             therapy, consideration should be given to draining the effusion prior to dosing;
             however, if, in the investigator's opinion, the effusion represents progression of
             disease, the patient should be discontinued from study therapy