A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients

You may be eligible if

• All patients must have biopsy proven ovarian cancer as determined by evaluation in the Laboratory of Pathology, NCI.
• Germ cell and borderline histologies are specifically excluded.
• Patients must have FIGO stage III and IV disease, or FIGO Stage IIC disease with poorly differentiated histology, and will undergo attempted surgical debulking prior to the initiation of chemotherapy.
• Prior chemotherapy or radiation therapy will make a patient ineligible.
• Performance status: less than or equal to ECOG 2.
• Patients must have the following end organ function:
• No brain involvement.
• No history of myocardial infarction, cardiac arrhythmias requiring
• therapy, right bundle branch block with left anterior hemiblock, and left bundle branch block.
• Renal function: creatinine clearance greater than or equal to 60 cc/min; patients with ureteral obstruction must have this corrected prior to starting therapy.
• Hepatic function: normal coagulation parameters, serum transaminases within 3 times upper limit of normal.
• Neurologic function: no preexisting dysfunction greater than grade 1 (exclusive of mild vibratory delay).
• No recent history of active GI bleeding.
• Hematologic parameters prior to starting cycle 1 of therapy: total granulocyte count greater than 2000 and platelet count greater than 100,000.
• Patients may not have had prior history of invasive malignancy with the exception of nonmelanoma skin cancer curatively treated.
• Patients must be able to give written informed consent and express a willingness to meet all of the expected requirements of the protocol.
• Patients must be able to begin therapy within 8 weeks of staging laparotomy and should have a central venous catheter placed for infusion of chemotherapy.
• All patients must be registered by calling the Orkand Corporation at 402-1732 between the hours of 8:30 AM and 5:00 PM; eligibility criteria will be queried.