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