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 (NCT #01595061)

Who is this study for? Adult women with squamous cell carcinoma of the vulva
Status: Unknown
Location: See all (193) locations...
Intervention Type: Drug, Procedure, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial studies how well radiation therapy works when given with gemcitabine hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva that has spread from where it started to nearby tissue or lymph nodes. 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, by stopping them from dividing, or by stopping them from spreading. Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska Oncology and Hematology LLC
Anchorage
Alaska Women's Cancer Care
Anchorage
Anchorage Associates in Radiation Medicine
Anchorage
Anchorage Oncology Centre
Anchorage
Anchorage Radiation Therapy Center
Anchorage
Katmai Oncology Group
Anchorage
Providence Alaska Medical Center
Anchorage
Alabama
University of Alabama at Birmingham Cancer Center
Birmingham
California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange
Connecticut
Hartford Hospital
Hartford
The Hospital of Central Connecticut
New Britain
Delaware
Beebe Medical Center
Lewes
Christiana Care Health System-Christiana Hospital
Newark
Christiana Gynecologic Oncology LLC
Newark
Delaware Clinical and Laboratory Physicians PA
Newark
Helen F Graham Cancer Center
Newark
Medical Oncology Hematology Consultants PA
Newark
Beebe Health Campus
Rehoboth Beach
TidalHealth Nanticoke / Allen Cancer Center
Seaford
Christiana Care Health System-Wilmington Hospital
Wilmington
Georgia
Augusta University Medical Center
Augusta
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah
Hawaii
The Cancer Center of Hawaii-Pali Momi
'aiea
Kapiolani Medical Center for Women and Children
Honolulu
Queen's Medical Center
Honolulu
The Cancer Center of Hawaii-Liliha
Honolulu
University of Hawaii Cancer Center
Honolulu
Idaho
Saint Luke's Cancer Institute - Boise
Boise
Saint Luke's Cancer Institute - Fruitland
Fruitland
Saint Luke's Cancer Institute - Meridian
Meridian
Saint Luke's Cancer Institute - Nampa
Nampa
Saint Luke's Cancer Institute - Twin Falls
Twin Falls
Illinois
Rush - Copley Medical Center
Aurora
Illinois CancerCare-Bloomington
Bloomington
Saint Joseph Medical Center
Bloomington
Illinois CancerCare-Canton
Canton
Memorial Hospital of Carbondale
Carbondale
SIH Cancer Institute
Carterville
Illinois CancerCare-Carthage
Carthage
Centralia Oncology Clinic
Centralia
University of Chicago Comprehensive Cancer Center
Chicago
Carle on Vermilion
Danville
Cancer Care Specialists of Illinois - Decatur
Decatur
Decatur Memorial Hospital
Decatur
Carle Physician Group-Effingham
Effingham
Crossroads Cancer Center
Effingham
Illinois CancerCare-Eureka
Eureka
Illinois CancerCare-Galesburg
Galesburg
Western Illinois Cancer Treatment Center
Galesburg
Northwestern Medicine Cancer Center Delnor
Geneva
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale
Illinois CancerCare-Kewanee Clinic
Kewanee
Illinois CancerCare-Macomb
Macomb
Carle Physician Group-Mattoon/Charleston
Mattoon
Good Samaritan Regional Health Center
Mount Vernon
UC Comprehensive Cancer Center at Silver Cross
New Lenox
Cancer Care Center of O'Fallon
O'fallon
Illinois CancerCare-Ottawa Clinic
Ottawa
Radiation Oncology of Northern Illinois
Ottawa
Illinois CancerCare-Pekin
Pekin
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin
Illinois CancerCare-Peoria
Peoria
Methodist Medical Center of Illinois
Peoria
OSF Saint Francis Medical Center
Peoria
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria
Illinois CancerCare-Peru
Peru
Valley Radiation Oncology
Peru
Illinois CancerCare-Princeton
Princeton
Central Illinois Hematology Oncology Center
Springfield
Memorial Medical Center
Springfield
Southern Illinois University School of Medicine
Springfield
Springfield Clinic
Springfield
Southwest Illinois Health Services LLP
Swansea
Carle Cancer Center
Urbana
The Carle Foundation Hospital
Urbana
Rush-Copley Healthcare Center
Yorkville
Indiana
Parkview Hospital Randallia
Fort Wayne
Parkview Regional Medical Center
Fort Wayne
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis
Kentucky
Saint Elizabeth Medical Center South
Edgewood
University of Kentucky/Markey Cancer Center
Lexington
Louisiana
Woman's Hospital
Baton Rouge
Ochsner Baptist Medical Center
New Orleans
Ochsner Medical Center Jefferson
New Orleans
Massachusetts
Brigham and Women's Hospital
Boston
Dana-Farber Cancer Institute
Boston
Massachusetts General Hospital Cancer Center
Boston
Baystate Medical Center
Springfield
Maryland
Christiana Care - Union Hospital
Elkton
Michigan
Wayne State University/Karmanos Cancer Institute
Detroit
Weisberg Cancer Treatment Center
Farmington Hills
Borgess Medical Center
Kalamazoo
Bronson Methodist Hospital
Kalamazoo
West Michigan Cancer Center
Kalamazoo
Minnesota
Sanford Joe Lueken Cancer Center
Bemidji
Missouri
Parkland Health Center-Bonne Terre
Bonne Terre
Saint Francis Medical Center
Cape Girardeau
Southeast Cancer Center
Cape Girardeau
Capital Region Southwest Campus
Jefferson City
Mercy Hospital Joplin
Joplin
Delbert Day Cancer Institute at PCRMC
Rolla
Mercy Clinic-Rolla-Cancer and Hematology
Rolla
Barnes-Jewish Hospital
Saint Louis
Mercy Hospital Saint Louis
Saint Louis
Missouri Baptist Medical Center
Saint Louis
Saint Louis Cancer and Breast Institute-South City
Saint Louis
Washington University School of Medicine
Saint Louis
Sainte Genevieve County Memorial Hospital
Sainte Genevieve
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Missouri Baptist Sullivan Hospital
Sullivan
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills
Mississippi
University of Mississippi Medical Center
Jackson
Montana
Saint Patrick Hospital - Community Hospital
Missoula
North Carolina
Carolinas Medical Center/Levine Cancer Institute
Charlotte
AdventHealth Hendersonville
Hendersonville
Wake Forest University Health Sciences
Winston-salem
North Dakota
Sanford Bismarck Medical Center
Bismarck
Sanford Broadway Medical Center
Fargo
Sanford Clinic North-Fargo
Fargo
Sanford Roger Maris Cancer Center
Fargo
New Jersey
Cooper Hospital University Medical Center
Camden
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees
Nevada
Women's Cancer Center of Nevada
Las Vegas
New York
Women's Cancer Care Associates LLC
Albany
Ohio
Summa Health System - Akron Campus
Akron
UHHS-Chagrin Highlands Medical Center
Beachwood
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati
Case Western Reserve University
Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland
Cleveland Clinic Foundation
Cleveland
Ohio State University Comprehensive Cancer Center
Columbus
Grandview Hospital
Dayton
Hillcrest Hospital Cancer Center
Mayfield Heights
UHHS-Westlake Medical Center
Westlake
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa
Oregon
Saint Charles Health System
Bend
Clackamas Radiation Oncology Center
Clackamas
Providence Cancer Institute Clackamas Clinic
Clackamas
Bay Area Hospital
Coos Bay
Providence Newberg Medical Center
Newberg
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Saint Charles Health System-Redmond
Redmond
Pennsylvania
Jefferson Abington Hospital
Abington
Temple University Hospital
Philadelphia
Asplundh Cancer Pavilion
Willow Grove
Rhode Island
Women and Infants Hospital
Providence
South Carolina
AnMed Health Cancer Center
Anderson
Prisma Health Cancer Institute - Spartanburg
Boiling Springs
Prisma Health Cancer Institute - Easley
Easley
Gibbs Cancer Center-Gaffney
Gaffney
Greenville Health System Cancer Institute-Andrews
Greenville
Prisma Health Cancer Institute - Butternut
Greenville
Prisma Health Cancer Institute - Eastside
Greenville
Prisma Health Cancer Institute - Faris
Greenville
Prisma Health Greenville Memorial Hospital
Greenville
Saint Francis Hospital
Greenville
Gibbs Cancer Center-Pelham
Greer
Prisma Health Cancer Institute - Greer
Greer
Prisma Health Cancer Institute - Seneca
Seneca
Spartanburg Medical Center
Spartanburg
South Dakota
Sanford Cancer Center Oncology Clinic
Sioux Falls
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Texas
Parkland Memorial Hospital
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
Memorial Hermann Texas Medical Center
Houston
Washington
Providence Regional Cancer System-Aberdeen
Aberdeen
PeaceHealth Saint Joseph Medical Center
Bellingham
Providence Regional Cancer System-Centralia
Centralia
Swedish Cancer Institute-Edmonds
Edmonds
Providence Regional Cancer Partnership
Everett
Swedish Cancer Institute-Issaquah
Issaquah
Kadlec Clinic Hematology and Oncology
Kennewick
Providence Regional Cancer System-Lacey
Lacey
PeaceHealth Saint John Medical Center
Longview
Kaiser Permanente Washington
Seattle
Pacific Gynecology Specialists
Seattle
Swedish Medical Center-Ballard Campus
Seattle
Swedish Medical Center-Cherry Hill
Seattle
Swedish Medical Center-First Hill
Seattle
PeaceHealth United General Medical Center
Sedro-woolley
Providence Regional Cancer System-Shelton
Shelton
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - North
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Spokane Valley
PeaceHealth Southwest Medical Center
Vancouver
Providence Saint Mary Regional Cancer Center
Walla Walla
Providence Regional Cancer System-Yelm
Yelm
Wisconsin
University of Wisconsin Hospital and Clinics
Madison
Time Frame
Start Date: 2012-07-02
Completion Date: 2022-09-23
Participants
Target number of participants: 57
Treatments
Experimental: Treatment (IMRT, gemcitabine, cisplatin, surgery)
Patients undergo 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.
Related Therapeutic Areas
Sponsors
Leads: Gynecologic Oncology Group
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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