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.
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 < 2.0 mg/dL (performed within 28 days from signing consent form)
Patients with stage T1N0 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
Single group
Cisplatin
DrugGiven IV
External Beam Radiation Therapy
RadiationUndergo EBRT
Nelfinavir
DrugGiven PO
Recommended phase II dose (RP2D) of nelfinavir
Defined as the dose for which the isotonic estimate of the dose limiting toxicity (DLT) rate is closest to the target DLT rate of 30%. If there are ties, the higher dose will be chosen as the RP2D when the isotonic estimate is lower than 30%, and the lower dose will be chosen when the isotonic estimate is greater than or equal to 30%.
Incidence of adverse events
Results from the dose escalation phase of study will be summarized by a tabulation of the number of patients treated and the number who experience a DLT at each dose level tested. Comprehensive safety data on all toxicities will be tabulated by type, grade, duration, attribution to treatment, and administered dose level. A patient level summary by worst grade toxicity will be included. Laboratory data and concomitant medications associated with episodes of toxicity will be summarized. Will also report the number of patients who discontinue therapy and the reasons for discontinuation.
Progression-free survival
Will be estimated using the product-limit method developed by Kaplan and Meier. Will report rates at specific times (e.g., at 6 and 12 months) and medians, if attained, with corresponding 95% confidence interval.
Overall survival
Will be estimated using the product-limit method developed by Kaplan and Meier. Will report rates at specific times (e.g., at 6 and 12 months) and medians, if attained, with corresponding 95% confidence interval.
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
