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

July 02, 2012
369251
Cancer-Gynecologic, Cancer
Tashanna Myers, MD
  • D’Amour Center for Cancer Care, 3350 Main Street, Springfield, MA
  • Baystate Franklin Medical Center, 164 High Street, Greenfield, MA
The purpose of this study is to find out if radiation therapy along with the addition of the drugs, cisplatin and gemcitabine, works and to find out what side effects or surgical complications are caused by treatment with this combination.

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


Recruiting
2
Laura Sorci
413-794-3188