A Phase I Study of Nelfinavir and Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Vulvar Cancer Not Amenable to Surgical Resection
This phase I trial studies the side effects and best dose of nelfinavir when given together with cisplatin and external beam radiation therapy in treating patients with vulvar cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery. Nelfinavir is an antiviral drug normally used to treat human immunodeficiency virus (HIV). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving nelfinavir, cisplatin, and external beam radiation therapy may work better than giving only cisplatin and external beam radiation therapy in treating patients with vulvar cancer.
• All patients with primary, previously untreated, histologically confirmed invasive carcinoma of the vulva (any cell type) not amenable to surgical excision. Clinical stages T2-T4, N0-3, M0. Hematoxylin \& eosin (H \& E) stained slide showing documentation of the primary invasive cancer is required. All specimens of primary tumor require documentation of type
• Absolute neutrophil count (ANC) \>= 1,500/microliter (performed within 28 days from signing consent form)
• Platelet count \>= 100,000/microliter (performed within 28 days from signing consent form)
• Creatinine \< 2.0 mg/dL (performed within 28 days from signing consent form)
• Total bilirubin =\< 1.5 times normal (performed within 28 days from signing consent form)
• Glutamic-oxaloacetic transaminase (SGOT) =\< 3 times normal (performed within 28 days from signing consent form)
• Patients with an Eastern Cooperative Oncology Group/Gynecologic Oncology Group (ECOG/GOG) performance status of 0, 1, or 2
• Patients with ureteral obstruction must be treated with stent or nephrostomy tube
• Patients must be consented within twelve (12) weeks of diagnosis or must be restaged
• Patients of childbearing potential must use an effective form of birth control. Patients receiving oral contraceptives should be instructed that alternate or additional contraceptive measures should be used during therapy with VIRACEPT.
• Confirmed seronegative HIV status within 3 months of signing consent
• Patients must have signed an approved informed consent and authorization permitting release of personal health information