Study: NCT01485731

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nelfinavir
Description: Nelfinavir (NFV) will be prescribed orally twice daily for 7 days prior to initiation of cisplatin and pelvic radiation at the starting dose level, 875 mg BID

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: Cisplatin at 40 mg/m2 (maximum total dose of 70 mg per week), will be infused intravenously once per week on either Day 1, 2, 3, 4, or 5 of weeks 2 to 6, preferably approximately four hours prior to radiation therapy. One additional cycle of cisplatin will be given either week 7 or 8 for a total of 6 cycles of cisplatin. Patients are not to be dosed more than 70 mg/week.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Pelvic External Beam Radiation Therapy
Description: Pelvic external beam radiation therapy (PEBRT) will be delivered in combination with weekly IV cisplatin (40mg/mg2) and twice daily oral NFV.PEBRT should be delivered once each day during the business week (Monday to Friday) according to the acceptable standards of care as prescribed by the treating radiation oncologist(s). The radiation therapy should consist of whole pelvic external beam radiation therapy (WPEBRT) with or without a parametrial boost (PB). PEBRT will be interdigitated with one administration of intrauterine brachytherapy (BT) given on any business day of week 7 or 8.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Brachytherapy
Description: PEBRT will be interdigitated with one administration of intrauterine brachytherapy (BT) given on any business day of week 7 or 8.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Pharmacokinetic Sampling
Description: Serum levels of Nelfinavir will be assayed at the following 3 time points: 5-8 days after initiation of NFV single agent (on Day 5, 6, or 7 of week 1 or day 1 of week 2), 1 week after combined NFV and cisplatin pelvic radiation (on day 15, 16, or 17 if start on Monday) for measurement of steady state, and at the completion of treatment (within the last 3 days of radiation in week 6). Blood samples will be taken before drug administration on the day of the sample to make sure the concentrations are actually at a minimum and before tumor biopsies.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Cervical Biopsy
Description: Three punch biopsies of cervical tumor will be obtained during office visit at each time point (for PCR, IHC, and banked for future research). NFV serum levels will be obtained once NFV has been started (day 5-8 pre chemoradiation and at completion of chemoradiation) before each cervical biopsy

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Pelvic Examination
Description: Pre-Treatment, at the end of treatment +/- 1 week, every 3 months +/- 2 weeks after therapy (x 1 year)

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Pap Smear
Description: Recommended. Every 3 months +/- 2 weeks after therapy (x 1 year)

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Audiogram
Description: Required in patients with history of hearing loss; 28 days within starting treatment and every other cycle.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Proctoscopy
Description: Optional. Pre-Treatment

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Cytoscopy
Description: Optional. Pre-Treatment

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Renal Ultrasound
Description: Optional. Pre-Treatment

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: CT Scan
Description: CT Scan of Chest/Abdomen/Pelvis, pre-treatment,Immediately at end of trial +/- 1 week, Every 3 months +/- 2 weeks after therapy (x 1 year)

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Whole Body PET/CT Scan
Description: In lieu of CT Scan, pre-treatment,Immediately at end of trial +/- 1 week, Every 3 months +/- 2 weeks after therapy (x 1 year)