Phase II Trial of Combination Pemetrexed (Alimta) and Carboplatin (Paraplatin) in Platinum Sensitive Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Carcinoma

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.

- Bidimensionally measurable disease which can be measured by physical examination or
by means of medical imaging techniques (measurable disease).

- OR Two confirmed serum CA-125 levels greater than or equal to 70 u/ml (or 2x 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 be at least 18 years of age.

- Patients must have a GOG performance status of 0, l, or 2.

- WBC > 3,00/mm3

- Neutrophils > 1,500/mm3

- Platelets > 100,000/mm3

- Total Bilirubin < 1.5 ULN

- Calculated creatinine clearance > 45 ml/min

- ALT/AST < 3 x ULN (no liver mets) ALT/AST < 5 x ULN (with liver mets)

- SGOT, SGPT, alkaline phosphatase ≤ three times the upper normal institutional limits.

- All labs must be drawn within 4 weeks prior to entry to the study

- 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 NSAID intake for 2 days
before, day of, and 2 days after each chemotherapy treatment. Low dose 80mg aspirin
and 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, bloodwork and any clinically indicated imaging
studies within 4 weeks prior to study enrollment.

- Baseline folate and homocysteine blood levels.

- 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 (≥ 4500cGy) 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.