Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva
Condition: Stage III Vulvar Cancer AJCC v7; Stage IIIA Vulvar Cancer AJCC v7; Stage IIIB Vulvar Cancer AJCC v7; Stage IIIC Vulvar Cancer AJCC v7; Stage IVA Vulvar Cancer AJCC v7; Vulvar Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Vulvar Neoplasms
Intervention: Cisplatin; Gemcitabine Hydrochloride; Intensity-Modulated Radiation Therapy; Therapeutic Conventional Surgery
Intervention description: Given IV; Given IV; Undergo IMRT; Undergo local core biopsy or surgical excision
Intervention MeSH terms: Cisplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well radiation therapy works when given with gemcitabine
      hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva
      that has spread from where it started to nearby tissue or lymph nodes. Specialized radiation
      therapy that delivers a high dose of radiation directly to the tumor may kill more tumor
      cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine
      hydrochloride and 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.
      Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more
      tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with locally advanced, previously untreated squamous cell carcinoma of the
             vulva

          -  Patients with T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by
             standard radical vulvectomy

          -  Absolute neutrophil count (ANC) >= 1,500/mcl

          -  Platelets >= 100,000/mcl

          -  Creatinine =< 1.5 times institutional upper limit of normal (ULN) OR calculated
             creatinine clearance >= 60 mL/min

          -  Bilirubin =< 1.5 x ULN

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN

          -  Alkaline phosphatase =< 3 x ULN

          -  Patients judged capable of tolerating a radical course of chemoradiation therapy

          -  Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG)
             protocol, if one exists; in general, this would refer to any active GOG Phase III
             protocol or Rare Tumor protocol for the same patient population

          -  Patients must have signed an approved informed consent and authorization permitting
             release of personal health information

          -  Patients with a GOG performance status of 0, 1, or 2

        Exclusion Criteria:

          -  Patients with recurrent carcinoma of the vulva regardless of previous treatment

          -  Patients who have received prior pelvic radiation or cytotoxic chemotherapy

          -  Patients with vulvar melanomas or sarcomas

          -  Patients with circumstances that will not permit completion of the study or the
             required follow-up

          -  Patients with evidence of active septicemia, severe infection, gastrointestinal
             bleeding or severe gastrointestinal symptoms requiring medical or surgical therapy

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
             being present within the last five years; patients are also excluded if their previous
             cancer treatment contraindicates this protocol therapy