A Phase I Study of Nelfinavir and Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Vulvar Cancer Not Amenable to Surgical Resection
M.D. Anderson Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVES: I. To determine the safety and dose limiting toxicities of nelfinavir in combination with cisplatin plus inguinal +/-pelvic radiation therapy for treatment of patients with unresectable T2-4, N0-3 vulvar carcinoma. II. To determine the recommended phase II dose of nelfinavir combined with chemoradiotherapy. SECONDARY OBJECTIVES: I. To determine recurrence site (local/distant), progression-free survival and overall survival. II. To determine the levels of Akt activity (and downstream effectors such as pGSK3, pEBP1) and p16INK4A in addition to the presence of human papil…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 \<…
Interventions
- DrugCisplatin
Given IV
- RadiationExternal Beam Radiation Therapy
Undergo EBRT
- DrugNelfinavir
Given PO
Location
- M D Anderson Cancer CenterHouston, Texas