Nelfinavir, Cisplatin and Radiation Therapy in Treating Patients with Stage II-IVA Cervical Cancer

Inclusion Criteria

• All patients with primary, previously untreated, histologically confirmed invasive carcinoma of the uterine cervix (any cell type). Clinical stages IIA, IIB, IIIA, IIIB, IVA. A representative hematoxylin (H) & eosin (E) stained slide showing documentation of the primary invasive cancer is required.
• Absolute neutrophil count (ANC) >= 1,500/uL (within 30 days prior to start of study treatment).
• Platelet count >= 100,000/uL (within 30 days prior to start of study treatment).
• Creatinine < 2.0 mg/dL (within 30 days prior to start of study treatment).
• Total Bilirubin =< 1.5 times normal (within 30 days prior to start of study treatment).
• Serum glutamic oxaloacetic transaminase (SGOT) =< 3 times normal (within 30 days prior to start of study treatment).
• Patients with an Eastern Cooperative Oncology Group (ECOG)/Gynecologic Oncology Group (GOG) Performance Status of 0, 1, or 2.
• Patients with ureteral obstruction must be treated with stent or nephrostomy tube
• 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 human immunodeficiency virus (HIV) status within 3 months prior to start of study treatment.
• Patients must have signed an approved informed consent and authorization permitting release of personal health information.

Exclusion Criteria

• Patients with Stage IA, IB or IVB 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.
• Patients who have circumstances that will not permit completion of this study or the required follow-up.
• Patients who are pregnant at the time of diagnosis and do not wish pregnancy termination prior to initiation of treatment.
• Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields.
• Patients with other concomitant malignancies (with the exception of non-melanoma skin cancer).
• Patients with gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn’s, ulcerative colitis).
• Patients with poorly controlled diabetes mellitus despite medication.
• Patients taking anti-arrhythmic agents such as amiodarone, quinidine, rifampin, ergot derivatives such as ergotamine, St John’s Wort, 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors such as lovastatin, neuroleptic such as pimozide, sedatives such as midazolam and triazolam among other CYP3A4 and CYP2C19 substrates.
• Patients with Phenylketonuria.