A Study of Nelfinavir Added to Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Cervical Cancer (II-IVA)

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 H & E stained slide showing documentation of the primary
invasive cancer is required.

- Patients must have adequate bone marrow, renal and hepatic function:

Laboratory work must be performed within 30 days prior to start of study treatment.

ANC ≥ 1,500/μL; Platelet count ≥ 100,000/μL; Creatinine < 2.0 mg/dL; Total Bilirubin ≤ 1.5
times normal; SGOT ≤ 3 times normal.

- Patients with a ECOG/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 HIV status within 3 months prior to start of study treatment.

- Patients must be at least 18 years of age.

- 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), who had (or have) any evidence of other cancer present within the last 5
years.

- Patients with GI tract disease resulting in an inability to take oral medication,
malabsorption syndrome, a requirement for 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-arythmic agents such as amiodarone, quinidine, rifampin, ergot
derivatives such as ergotamine, St John's Wort, 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