Safety Study of Nelfinavir + Cisplatin + Pelvic Radiation Therapy to Treat Cervical Cancer

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Nelfinavir will increase the efficacy of Cisplatin based chemo- radiation therapy for locally advanced cervical cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Treatments: Cisplatin; Nelfinavir

Criteria

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.

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

• 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 GOG Performance Status of 0, 1, or 2.

• Patients with ureteral obstruction must be treated with stent or nephrostomy tube.

• Patients must be entered within eight weeks of diagnosis.

• 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. "

• Seronegative HIV status.

• 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-arrhythmic agents such as amiodarone, quinidine, rifampin, ergot derivatives such as ergotamine, St Johs 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.