A Phase II Trial Evaluating Cisplatin (NSC #119875) and Gemcitabine (NSC #613327) Concurrent With Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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

- 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

- No patients with recurrent carcinoma of the vulva regardless of previous treatment

- No patients with vulvar melanomas or sarcomas

PATIENT CHARACTERISTICS:

- 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 times ULN

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 times ULN

- Alkaline phosphatase ≤ 3 times ULN

- Patients judged capable of tolerating a radical course of chemoradiation therapy

- 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

- No patients with circumstances that will not permit completion of the study or the
required follow-up

- No 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

PRIOR CONCURRENT THERAPY:

- No patients who have received prior pelvic radiation or cytotoxic chemotherapy

- Patients are excluded if their previous cancer treatment contraindicates this
protocol therapy