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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Vulvar Cancer

Thank you

Trial Information

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


OBJECTIVES:

Primary

- To determine the efficacy of cisplatin, gemcitabine hydrochloride (gemcitabine), 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

- 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.

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

- 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: This is a multicenter study.

Patients undergo intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks.
Patients also receive gemcitabine hydrochloride 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


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete pathologic response (pCR) evaluated as the frequency of complete clinical and pathologic response after primary therapy

Safety Issue:

No

Principal Investigator

Neil S. Horowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber/Brigham and Women's Cancer Center

Authority:

United States: National Cancer Institutie

Study ID:

GOG-0279

NCT ID:

NCT01595061

Start Date:

August 2012

Completion Date:

Related Keywords:

  • Vulvar Cancer
  • squamous cell carcinoma of the vulva
  • stage IIIA vulvar cancer
  • stage IIIB vulvar cancer
  • stage IIIC vulvar cancer
  • stage IVA vulvar cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Vulvar Neoplasms

Name

Location

Cleveland Clinic Foundation Cleveland, Ohio  44195
Washington University School of Medicine Saint Louis, Missouri  63110
Abington Memorial Hospital Abington, Pennsylvania  19001
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Hartford Hospital Hartford, Connecticut  06102-5037
Baystate Medical Center Springfield, Massachusetts  01199
Carolinas Medical Center Charlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Beebe Medical Center Lewes, Delaware  19958
Union Hospital of Cecil County Elkton MD, Maryland  21921
Memorial Medical Center Springfield, Illinois  62781
Phelps County Regional Medical Center Rolla, Missouri  65401
Case Western Reserve University Cleveland, Ohio  44106
Wayne State University Detroit, Michigan  48202
Indiana University Medical Center Indianapolis, Indiana  46202
University of Texas Southwestern Medical Center Dallas, Texas  
Providence Saint Joseph Medical Center Burbank, California  91505-4866
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio  44124
The Hospital of Central Connecticut New Britain, Connecticut  06050
Saint Joseph's-Candler Health System Savannah, Georgia  31405
University of Hawaii Honolulu, Hawaii  96813
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Springfield, Missouri  65802
Saint John's Hospital Springfield, Missouri  65804
Cox Medical Center Springfield, Missouri  65807
Cooper Hospital University Medical Center Camden, New Jersey  08103
Sanford Cancer Center-Oncology Clinic Sioux Falls, South Dakota  57104
Cancer Care Associates-Yale Tulsa, Oklahoma  74136-1929
Women and Infants Hospital Providence, Rhode Island  02905
Lake University Ireland Cancer Center Mentor, Ohio  44060
Sudarshan K Sharma MD Limted-Gynecologic Oncology Hinsdale, Illinois  60521
Summa Akron City Hospital Akron, Ohio  44304
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota  57117-5134
Christiana Care Health System-Christiana Hospital Newark, Delaware  19718
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio  44111
Women's Cancer Care Associates LLC Albany, New York  12208