Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva

PRIMARY OBJECTIVES:

I. To determine the efficacy of cisplatin, gemcitabine (gemcitabine hydrochloride), and
intensity-modulated radiation therapy (IMRT) in achieving a complete pathologic response when
used for the primary treatment of locally-advanced squamous cell carcinoma of the vulva.

SECONDARY OBJECTIVES:

I. To determine the efficacy of cisplatin, gemcitabine, and IMRT in achieving a complete
clinical response when used for the primary treatment of locally-advanced squamous cell
carcinoma of the vulva.

II. To determine the vulvar progression-free survival and groin progression-free survival in
women treated with cisplatin, gemcitabine and IMRT for locally advanced vulvar carcinoma.

III. To determine the toxicity and surgical morbidity of the combined modality approach of
cisplatin, gemcitabine and IMRT followed by reduced-scope surgery for the treatment of
locally-advanced vulvar carcinoma.

OUTLINE:

Patients undergo IMRT 5 days a week for 6 weeks. Patients also receive gemcitabine
hydrochloride intravenously (IV) over 30 minutes and cisplatin IV over 60 minutes weekly for
6 weeks in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks
after completion of chemoradiation patients undergo local core biopsy to confirm response or
surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

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