Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer

DISEASE CHARACTERISTICS:

• Histologically or pathologically confirmed ovarian epithelial carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma

  • Stage III disease

• Meets 1 of the following criteria:

  • No prior treatment and no more than 6 months since primary surgery
  • Platinum-sensitive at second-look surgery with no prior cisplatin therapy
• Must have been optimally debulked to less than 2-cm residual individual tumor plaques or, if suboptimally debulked at first surgery, had chemical debulking
• No mixed Müllerian tumor or borderline ovarian tumor
• No Central nervous system (CNS) or brain metastases

PATIENT CHARACTERISTICS:

• Gynecologic Oncology Group performance status 0-2
• White blood cell count(WBC) ≥ 3,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Serum bilirubin ≤ 2 times upper limit of normal (ULN)
• Aspartate aminotransferase (AST)and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal
• Creatinine clearance ≥ 45 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 3 months after discontinuation of study drug
• No psychological, familial, sociological, or geographical conditions that do not permit medical follow-up or compliance with the study protocol
• No unstable or preexisting major medical conditions, except cancer-related abnormalities
• No medical life-threatening complications of their malignancies
• No known severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, active uncontrolled infection, or HIV)
• No serious active uncontrolled infections
• No inadequately controlled hypertension (defined as systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg on antihypertensive medications)
• No New York Heart Association grade II-IV congestive heart failure
• No weight loss between 5 to ≤ 10% within the past 14 days that is not related to ascites or paracentesis
• No prior hypertensive crisis or hypertensive encephalopathy
• No myocardial infarction, cerebrovascular accident, transient ischemic attack, or unstable angina within the past 6 months
• No evidence of uncontrollable nausea
• No clinically significant or symptomatic peripheral vascular disease (e.g., aortic aneurysm or aortic dissection)
• No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
• No pre-existing clinically significant hearing loss
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or adequately treated stage I or II cancer from which the patient is in complete remission
• No known hypersensitivity to any component of pemetrexed disodium
• Able to take folic acid, vitamin B_12, and dexamethasone according to protocol
• No presence of third-space fluid that cannot be controlled by drainage
• No inability to comply with study and/or follow-up procedures

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• May have received up to 4 courses of carboplatin and paclitaxel IV as neoadjuvant chemotherapy for advanced, unresectable disease
• Concurrent low-dose aspirin therapy (i.e., 325 mg/day) allowed

• Concurrent ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) with short elimination half-lives allowed provided ≥ 1 of the following criteria is met:

  • Creatinine clearance (CrCl) > 80 mL/min (i.e., normal renal function)
  • CrCl 45-79 mL/min (i.e., mild to moderate renal insufficiency) AND NSAID dosing interrupted for a period of 2 days before, during, and 2 days after administration of pemetrexed disodium
• Concurrent NSAIDs or salicylates with long half-lives (e.g., naproxen, piroxicam, diflunisal, or nabumetone) allowed provided NSAID dosing is interrupted for at least 5 days before, during, and 2 days after administration of pemetrexed disodium
• No concurrent antineoplastic or antitumor agents not part of the study therapy (i.e., chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy)
• No other concurrent investigational agents