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)
Patients with stage T1N0 disease
Patients who have known metastases to other organs outside the radiation field at the time of the original clinical and surgical staging
Patients who have received previous pelvic or abdominal radiation, cytotoxic chemotherapy, or previous therapy of any kind for this malignancy
Patients with septicemia or severe infection
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator