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

Status: Recruiting
Phase: Phase 2
Diagnosis: GYN: Vulvar Cancer
NCT ID: NCT01595061 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-452


This phase II trial studies how well giving radiation therapy together with gemcitabine hydrochloride and cisplatin work in treating patients with locally advanced squamous cell carcinoma of the vulva. 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 or by stopping them from dividing. Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Neil Horowitz, MD, Brigham and Women's Hospital

Site-responsible Investigators:
Whitfield Growdon, MD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Christin Whalen, 617-582-7738, cwhalen@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility 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
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