Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer

- Before patients receive any chemotherapy treatments they will be given three medications
to prevent side effects from the chemotherapy drugs. These medications are vitamin B12,
folic acid and dexamethasone.

- Chemotherapy treatments will be given intravenously in the outpatient clinic. Pemetrexed
will be given first and will take 10 minutes to infuse followed by carboplatin which
will take 30-45 minutes to infuse. These treatments will be repeated once every three
weeks for 6 cycles of chemotherapy (18 weeks).

- Before each chemotherapy treatment the following tests and procedures will be performed:
physical exam and medical history; evaluation of ability to undertake daily activities;
and blood tests.

- After every 2 cycles of chemotherapy (every 6 weeks) patients will have a CT or MRI scan
to measure how well their cancer is responding to treatment.

- The study treatment will last for 6 cycles of chemotherapy as long as the tumor does not
grow and the patient isn't experiencing any severe side effects.

Inclusion Criteria:

- Diagnosis of platinum-sensitive recurrence of epithelial ovarian cancer, primary
peritoneal cancer, or fallopian tube cancer

- The following histologic subtypes are eligible: papillary serous, endometrioid,
mucinous, clear cell, adenocarcinomas, transitional, and mixtures of the above.

- At least one measurable lesion according to RECIST criteria via CT or MRI scan

- Received a platinum-containing regimen at initial diagnosis

- ECOG performance status of 0,1 or 2

- 18 years of age or older

- Life expectancy of greater than 12 weeks

- WBC > 1,500/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)

- Complete recovery from completion of previous chemotherapy or biologic therapy

- Negative pregnancy test and agree to practice effective method of birth control

Exclusion Criteria:

- Patients with sarcomatous, stromal, or germ cell elements

- Prior pelvic radiotherapy > 25% of bone marrow

- Uncontrolled medical problem that in the opinion of the investigator would preclude
safe administration of the study drugs

- Past history of bone marrow transplantation or stem cell support

- Known history of CNS metastasis unless the patient has had treatment with surgery or
radiation therapy, is neurologically stable, and does not require oral or intravenous
corticosteroids or anticonvulsants

- Prior malignancy except adequately treated carcinoma in situ of the uterine cervix,
incidental stage I endometrial cancer, basal cell or squamous cell skin cancer or
breast cancer (invasive or ductal carcinoma in situ) of which the patient has been
disease-free for at least five years

- Routine prophylactic use of G-CSF or GM-CSF or blood transfusions within 2 weeks

- Clinically significant cardiac disease as defined by: history of unstable angina
within 6 months; history of symptomatic ventricular arrhythmias; history of congestive
heart failure; history of myocardial infarction within 6 months

- Uncontrolled hypercalcemia or diabetes mellitus

- Any signs of intestinal obstruction with bowel function and/or nutrition

- Grade 2 or greater peripheral neuropathy

- Participation in an investigational study within three weeks

- History of anaphylactic shock to prior platinum chemotherapy

- History of psychiatric disability or other central nervous system disorder