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

• Sponsor: Gynecologic Oncology Group (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01595061
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 57
• Locations: 193
• Arm: 1
• Anticipated Duration (Months): 122.7
• Patients Per Site: 0.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stage III Vulvar Cancer AJCC v7; Stage IIIA Vulvar Cancer AJCC v7; Stage IIIB Vulvar Cancer AJCC v7; Stage IIIC Vulvar Cancer AJCC v7; Stage IVA Vulvar Cancer AJCC v7; Vulvar Squamous Cell Carcinoma	Drug: Cisplatin; Drug: Gemcitabine Hydrochloride; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Therapeutic Conventional Surgery	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. 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:

1. 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.

2. 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.

3. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: Jul 2, 2012
• Actual Primary Completion Date: Sep 23, 2020
• Anticipated Study Completion Date: Sep 23, 2022

Arms and Interventions

Arm

Intervention/Treatment

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.

Drug: Cisplatin; Given IV; Other Names: Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone''s Chloride Peyrone''s Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin ; Drug: Gemcitabine Hydrochloride; Given IV; Other Names: dFdCyd Difluorodeoxycytidine Hydrochloride FF 10832 FF-10832 FF10832 Gemcitabine HCI Gemzar LY-188011 LY188011 ; Radiation: Intensity-Modulated Radiation Therapy; Undergo IMRT; Other Names: IMRT Intensity Modulated RT Intensity-Modulated Radiotherapy Radiation, Intensity-Modulated Radiotherapy ; Procedure: Therapeutic Conventional Surgery; Undergo local core biopsy or surgical excision

Outcome Measures

Primary Outcome Measures

1. Complete Pathologic Response [6 -8 weeks after completion of chemo-radiation]

   Percentage of participants with complete pathologic response. Complete pathologic response is defined as negative local core biopsy or FNA specimens following primary chemo-radiation therapy.

Secondary Outcome Measures

1. Complete Clinical Response [6-8 weeks after completion of chemo-radiation]

   Percentage of participants with complete clinical response. Complete clinical response is defined as no clinical/radiographic evidence of primary disease (vulva or groin) following primary chemo-radiation therapy.

2. Adverse Events (Grade 3 or Higher) During Treatment Period [During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.]

   Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.

3. Progression-free Survival (PFS) [From study entry to disease progression, death or date of last contact, whichever occurs first. The median for observed PFS was 26.2 month with a range from 1.5 months to 82.4 months]

   Estimate for probability of progression free survival by Kaplan-Meier method, where progression-free survival is defined as the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. PFS is censored in patients who are alive and have not progressed. Progression is assessed by RECIST 1.1

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Cancer Center	Birmingham	Alabama	United States	35233
2	Anchorage Associates in Radiation Medicine	Anchorage	Alaska	United States	98508
3	Anchorage Radiation Therapy Center	Anchorage	Alaska	United States	99504
4	Alaska Breast Care and Surgery LLC	Anchorage	Alaska	United States	99508
5	Alaska Oncology and Hematology LLC	Anchorage	Alaska	United States	99508
6	Alaska Women's Cancer Care	Anchorage	Alaska	United States	99508
7	Anchorage Oncology Centre	Anchorage	Alaska	United States	99508
8	Katmai Oncology Group	Anchorage	Alaska	United States	99508
9	Providence Alaska Medical Center	Anchorage	Alaska	United States	99508
10	Providence Saint Joseph Medical Center/Disney Family Cancer Center	Burbank	California	United States	91505
11	UC Irvine Health/Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
12	Hartford Hospital	Hartford	Connecticut	United States	06102
13	The Hospital of Central Connecticut	New Britain	Connecticut	United States	06050
14	Beebe Medical Center	Lewes	Delaware	United States	19958
15	Christiana Gynecologic Oncology LLC	Newark	Delaware	United States	19713
16	Delaware Clinical and Laboratory Physicians PA	Newark	Delaware	United States	19713
17	Helen F Graham Cancer Center	Newark	Delaware	United States	19713
18	Medical Oncology Hematology Consultants PA	Newark	Delaware	United States	19713
19	Christiana Care Health System-Christiana Hospital	Newark	Delaware	United States	19718
20	Beebe Health Campus	Rehoboth Beach	Delaware	United States	19971
21	TidalHealth Nanticoke / Allen Cancer Center	Seaford	Delaware	United States	19973
22	Christiana Care Health System-Wilmington Hospital	Wilmington	Delaware	United States	19801
23	Augusta University Medical Center	Augusta	Georgia	United States	30912
24	Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Savannah	Georgia	United States	31405
25	The Cancer Center of Hawaii-Pali Momi	'Aiea	Hawaii	United States	96701
26	Queen's Medical Center	Honolulu	Hawaii	United States	96813
27	University of Hawaii Cancer Center	Honolulu	Hawaii	United States	96813
28	The Cancer Center of Hawaii-Liliha	Honolulu	Hawaii	United States	96817
29	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
30	Saint Luke's Cancer Institute - Boise	Boise	Idaho	United States	83712
31	Saint Luke's Cancer Institute - Fruitland	Fruitland	Idaho	United States	83619
32	Saint Luke's Cancer Institute - Meridian	Meridian	Idaho	United States	83642
33	Saint Luke's Cancer Institute - Nampa	Nampa	Idaho	United States	83686
34	Saint Luke's Cancer Institute - Twin Falls	Twin Falls	Idaho	United States	83301
35	Rush - Copley Medical Center	Aurora	Illinois	United States	60504
36	Saint Joseph Medical Center	Bloomington	Illinois	United States	61701
37	Illinois CancerCare-Bloomington	Bloomington	Illinois	United States	61704
38	Illinois CancerCare-Canton	Canton	Illinois	United States	61520
39	Memorial Hospital of Carbondale	Carbondale	Illinois	United States	62902
40	SIH Cancer Institute	Carterville	Illinois	United States	62918
41	Illinois CancerCare-Carthage	Carthage	Illinois	United States	62321
42	Centralia Oncology Clinic	Centralia	Illinois	United States	62801
43	University of Chicago Comprehensive Cancer Center	Chicago	Illinois	United States	60637
44	Carle on Vermilion	Danville	Illinois	United States	61832
45	Cancer Care Specialists of Illinois - Decatur	Decatur	Illinois	United States	62526
46	Decatur Memorial Hospital	Decatur	Illinois	United States	62526
47	Carle Physician Group-Effingham	Effingham	Illinois	United States	62401
48	Crossroads Cancer Center	Effingham	Illinois	United States	62401
49	Illinois CancerCare-Eureka	Eureka	Illinois	United States	61530
50	Illinois CancerCare-Galesburg	Galesburg	Illinois	United States	61401
51	Western Illinois Cancer Treatment Center	Galesburg	Illinois	United States	61401
52	Northwestern Medicine Cancer Center Delnor	Geneva	Illinois	United States	60134
53	Sudarshan K Sharma MD Limited-Gynecologic Oncology	Hinsdale	Illinois	United States	60521
54	Illinois CancerCare-Kewanee Clinic	Kewanee	Illinois	United States	61443
55	Illinois CancerCare-Macomb	Macomb	Illinois	United States	61455
56	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois	United States	61938
57	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
58	UC Comprehensive Cancer Center at Silver Cross	New Lenox	Illinois	United States	60451
59	Cancer Care Center of O'Fallon	O'Fallon	Illinois	United States	62269
60	Illinois CancerCare-Ottawa Clinic	Ottawa	Illinois	United States	61350
61	Radiation Oncology of Northern Illinois	Ottawa	Illinois	United States	61350
62	Illinois CancerCare-Pekin	Pekin	Illinois	United States	61554
63	OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center	Pekin	Illinois	United States	61554
64	Illinois CancerCare-Peoria	Peoria	Illinois	United States	61615
65	OSF Saint Francis Radiation Oncology at Peoria Cancer Center	Peoria	Illinois	United States	61615
66	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
67	OSF Saint Francis Medical Center	Peoria	Illinois	United States	61637
68	Illinois CancerCare-Peru	Peru	Illinois	United States	61354
69	Valley Radiation Oncology	Peru	Illinois	United States	61354
70	Illinois CancerCare-Princeton	Princeton	Illinois	United States	61356
71	Central Illinois Hematology Oncology Center	Springfield	Illinois	United States	62702
72	Southern Illinois University School of Medicine	Springfield	Illinois	United States	62702
73	Springfield Clinic	Springfield	Illinois	United States	62702
74	Memorial Medical Center	Springfield	Illinois	United States	62781
75	Southwest Illinois Health Services LLP	Swansea	Illinois	United States	62226
76	Carle Cancer Center	Urbana	Illinois	United States	61801
77	The Carle Foundation Hospital	Urbana	Illinois	United States	61801
78	Rush-Copley Healthcare Center	Yorkville	Illinois	United States	60560
79	Parkview Hospital Randallia	Fort Wayne	Indiana	United States	46805
80	Parkview Regional Medical Center	Fort Wayne	Indiana	United States	46845
81	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202
82	Saint Elizabeth Medical Center South	Edgewood	Kentucky	United States	41017
83	University of Kentucky/Markey Cancer Center	Lexington	Kentucky	United States	40536
84	Woman's Hospital	Baton Rouge	Louisiana	United States	70817
85	Ochsner Baptist Medical Center	New Orleans	Louisiana	United States	70115
86	Ochsner Medical Center Jefferson	New Orleans	Louisiana	United States	70121
87	Christiana Care - Union Hospital	Elkton	Maryland	United States	21921
88	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
89	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
90	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
91	Baystate Medical Center	Springfield	Massachusetts	United States	01199
92	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan	United States	48201
93	Weisberg Cancer Treatment Center	Farmington Hills	Michigan	United States	48334
94	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
95	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
96	Borgess Medical Center	Kalamazoo	Michigan	United States	49048
97	Sanford Joe Lueken Cancer Center	Bemidji	Minnesota	United States	56601
98	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
99	Parkland Health Center-Bonne Terre	Bonne Terre	Missouri	United States	63628
100	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
101	Southeast Cancer Center	Cape Girardeau	Missouri	United States	63703
102	Capital Region Southwest Campus	Jefferson City	Missouri	United States	65109
103	Mercy Hospital Joplin	Joplin	Missouri	United States	64804
104	Delbert Day Cancer Institute at PCRMC	Rolla	Missouri	United States	65401
105	Mercy Clinic-Rolla-Cancer and Hematology	Rolla	Missouri	United States	65401
106	Saint Louis Cancer and Breast Institute-South City	Saint Louis	Missouri	United States	63109
107	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
108	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
109	Missouri Baptist Medical Center	Saint Louis	Missouri	United States	63131
110	Mercy Hospital Saint Louis	Saint Louis	Missouri	United States	63141
111	Sainte Genevieve County Memorial Hospital	Sainte Genevieve	Missouri	United States	63670
112	Mercy Hospital Springfield	Springfield	Missouri	United States	65804
113	CoxHealth South Hospital	Springfield	Missouri	United States	65807
114	Missouri Baptist Sullivan Hospital	Sullivan	Missouri	United States	63080
115	Missouri Baptist Outpatient Center-Sunset Hills	Sunset Hills	Missouri	United States	63127
116	Saint Patrick Hospital - Community Hospital	Missoula	Montana	United States	59802
117	Women's Cancer Center of Nevada	Las Vegas	Nevada	United States	89169
118	Cooper Hospital University Medical Center	Camden	New Jersey	United States	08103
119	MD Anderson Cancer Center at Cooper-Voorhees	Voorhees	New Jersey	United States	08043
120	Women's Cancer Care Associates LLC	Albany	New York	United States	12208
121	Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina	United States	28203
122	AdventHealth Hendersonville	Hendersonville	North Carolina	United States	28792
123	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
124	Sanford Bismarck Medical Center	Bismarck	North Dakota	United States	58501
125	Sanford Broadway Medical Center	Fargo	North Dakota	United States	58122
126	Sanford Clinic North-Fargo	Fargo	North Dakota	United States	58122
127	Sanford Roger Maris Cancer Center	Fargo	North Dakota	United States	58122
128	Summa Health System - Akron Campus	Akron	Ohio	United States	44304
129	UHHS-Chagrin Highlands Medical Center	Beachwood	Ohio	United States	44122
130	University of Cincinnati Cancer Center-UC Medical Center	Cincinnati	Ohio	United States	45219
131	Case Western Reserve University	Cleveland	Ohio	United States	44106
132	Cleveland Clinic Cancer Center/Fairview Hospital	Cleveland	Ohio	United States	44111
133	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
134	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210
135	Grandview Hospital	Dayton	Ohio	United States	45405
136	Hillcrest Hospital Cancer Center	Mayfield Heights	Ohio	United States	44124
137	UHHS-Westlake Medical Center	Westlake	Ohio	United States	44145
138	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
139	Oklahoma Cancer Specialists and Research Institute-Tulsa	Tulsa	Oklahoma	United States	74146
140	Saint Charles Health System	Bend	Oregon	United States	97701
141	Clackamas Radiation Oncology Center	Clackamas	Oregon	United States	97015
142	Providence Cancer Institute Clackamas Clinic	Clackamas	Oregon	United States	97015
143	Bay Area Hospital	Coos Bay	Oregon	United States	97420
144	Providence Newberg Medical Center	Newberg	Oregon	United States	97132
145	Providence Portland Medical Center	Portland	Oregon	United States	97213
146	Providence Saint Vincent Medical Center	Portland	Oregon	United States	97225
147	Saint Charles Health System-Redmond	Redmond	Oregon	United States	97756
148	Jefferson Abington Hospital	Abington	Pennsylvania	United States	19001
149	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
150	Asplundh Cancer Pavilion	Willow Grove	Pennsylvania	United States	19090
151	Women and Infants Hospital	Providence	Rhode Island	United States	02905
152	AnMed Health Cancer Center	Anderson	South Carolina	United States	29621
153	Prisma Health Cancer Institute - Spartanburg	Boiling Springs	South Carolina	United States	29316
154	Prisma Health Cancer Institute - Easley	Easley	South Carolina	United States	29640
155	Gibbs Cancer Center-Gaffney	Gaffney	South Carolina	United States	29341
156	Greenville Health System Cancer Institute-Andrews	Greenville	South Carolina	United States	29601
157	Saint Francis Hospital	Greenville	South Carolina	United States	29601
158	Prisma Health Cancer Institute - Butternut	Greenville	South Carolina	United States	29605
159	Prisma Health Cancer Institute - Faris	Greenville	South Carolina	United States	29605
160	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
161	Prisma Health Cancer Institute - Eastside	Greenville	South Carolina	United States	29615
162	Prisma Health Cancer Institute - Greer	Greer	South Carolina	United States	29650
163	Gibbs Cancer Center-Pelham	Greer	South Carolina	United States	29651
164	Prisma Health Cancer Institute - Seneca	Seneca	South Carolina	United States	29672
165	Spartanburg Medical Center	Spartanburg	South Carolina	United States	29303
166	Sanford Cancer Center Oncology Clinic	Sioux Falls	South Dakota	United States	57104
167	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota	United States	57117-5134
168	Parkland Memorial Hospital	Dallas	Texas	United States	75235
169	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas	United States	75390
170	Memorial Hermann Texas Medical Center	Houston	Texas	United States	77030
171	Providence Regional Cancer System-Aberdeen	Aberdeen	Washington	United States	98520
172	PeaceHealth Saint Joseph Medical Center	Bellingham	Washington	United States	98225
173	Providence Regional Cancer System-Centralia	Centralia	Washington	United States	98531
174	Swedish Cancer Institute-Edmonds	Edmonds	Washington	United States	98026
175	Providence Regional Cancer Partnership	Everett	Washington	United States	98201
176	Swedish Cancer Institute-Issaquah	Issaquah	Washington	United States	98029
177	Kadlec Clinic Hematology and Oncology	Kennewick	Washington	United States	99336
178	Providence Regional Cancer System-Lacey	Lacey	Washington	United States	98503
179	PeaceHealth Saint John Medical Center	Longview	Washington	United States	98632
180	Pacific Gynecology Specialists	Seattle	Washington	United States	98104
181	Swedish Medical Center-Ballard Campus	Seattle	Washington	United States	98107
182	Kaiser Permanente Washington	Seattle	Washington	United States	98112
183	Swedish Medical Center-First Hill	Seattle	Washington	United States	98122-4307
184	Swedish Medical Center-Cherry Hill	Seattle	Washington	United States	98122-5711
185	PeaceHealth United General Medical Center	Sedro-Woolley	Washington	United States	98284
186	Providence Regional Cancer System-Shelton	Shelton	Washington	United States	98584
187	MultiCare Deaconess Cancer and Blood Specialty Center - Valley	Spokane Valley	Washington	United States	99216
188	MultiCare Deaconess Cancer and Blood Specialty Center - Downtown	Spokane	Washington	United States	99204
189	MultiCare Deaconess Cancer and Blood Specialty Center - North	Spokane	Washington	United States	99218
190	PeaceHealth Southwest Medical Center	Vancouver	Washington	United States	98664
191	Providence Saint Mary Regional Cancer Center	Walla Walla	Washington	United States	99362
192	Providence Regional Cancer System-Yelm	Yelm	Washington	United States	98597
193	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• Gynecologic Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Neil S Horowitz, NRG Oncology

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 21, 2016

More Information

Publications

None provided.

• Responsible Party: Gynecologic Oncology Group
• ClinicalTrials.gov Identifier: NCT01595061
• Other Study ID Numbers: GOG-0279; NCI-2012-01964; CDR0000732793; GOG-0279; GOG-0279; U10CA180868; U10CA027469
• First Posted: May 9, 2012
• Last Update Posted: Dec 29, 2021
• Last Verified: Dec 1, 2021

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Vulvar Neoplasms; Gemcitabine; Cisplatin

Study Results

Participant Flow

Recruitment Details	GOG-0279 was activated on 07/02/2012 and closed to accrual on February 20, 2020.

Arm/Group Title	GEM+CIS+IMRT
Arm/Group Description	Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
Period Title: Overall Study
STARTED	57
COMPLETED	53
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	GEM+CIS+IMRT
Arm/Group Description	Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
Overall Participants	53
Age, Customized (Count of Participants)
20 - 29 years	1 1.9%
30 - 39 years	0 0%
40 - 49 years	6 11.3%
50 - 59 years	23 43.4%
60 - 69 years	10 18.9%
70 - 79 years	8 15.1%
>= 80 years	5 9.4%
Sex: Female, Male (Count of Participants)
Female	53 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 1.9%
Not Hispanic or Latino	52 98.1%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.9%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 1.9%
White	50 94.3%
More than one race	1 1.9%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Complete Pathologic Response
Description	Percentage of participants with complete pathologic response. Complete pathologic response is defined as negative local core biopsy or FNA specimens following primary chemo-radiation therapy.
Time Frame	6 -8 weeks after completion of chemo-radiation

Outcome Measure Data

Analysis Population Description

Eligible and treated

Arm/Group Title	GEM+CIS+IMRT
Arm/Group Description	Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
Measure Participants	53
Number (90% Confidence Interval) [percentage of participants]	73.6 138.9%

2. Secondary Outcome

Title	Complete Clinical Response
Description	Percentage of participants with complete clinical response. Complete clinical response is defined as no clinical/radiographic evidence of primary disease (vulva or groin) following primary chemo-radiation therapy.
Time Frame	6-8 weeks after completion of chemo-radiation

Outcome Measure Data

Analysis Population Description

Eligible and Treated

Arm/Group Title	GEM+CIS+IMRT
Arm/Group Description	Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
Measure Participants	53
Number (90% Confidence Interval) [percentage of participants]	71.7 135.3%

3. Secondary Outcome

Title	Adverse Events (Grade 3 or Higher) During Treatment Period
Description	Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
Time Frame	During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.

Outcome Measure Data

Analysis Population Description

Eligible and Treated

Arm/Group Title	GEM+CIS+IMRT
Arm/Group Description	Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
Measure Participants	53
Leukopenia	27 50.9%
Thrombocytopenia	20 37.7%
Neutropenia	20 37.7%
Anemia	20 37.7%
Other Investigations	7 13.2%
Other blood and lymphatic disorders	8 15.1%
Cardiac disorders	2 3.8%
Gastrointestinal disorders	10 18.9%
General disorders and administration site conditions	5 9.4%
Infections and infestations	5 9.4%
Injury, poisoning and procedural complications	20 37.7%
Metabolism and nutrition disorders	19 35.8%
Musculoskeletal and connective tissue disorders	2 3.8%
Peripheral sensory neuropathy	1 1.9%
Other nervous system disorders	2 3.8%
Renal and urinary disorders	1 1.9%
Reproductive system and breast disorders	7 13.2%
Respiratory, thoracic and mediastinal disorders	1 1.9%
Skin and subcutaneous tissue disorders	4 7.5%
Surgical and medical procedures	1 1.9%
Vascular disorders	5 9.4%

4. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	Estimate for probability of progression free survival by Kaplan-Meier method, where progression-free survival is defined as the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. PFS is censored in patients who are alive and have not progressed. Progression is assessed by RECIST 1.1
Time Frame	From study entry to disease progression, death or date of last contact, whichever occurs first. The median for observed PFS was 26.2 month with a range from 1.5 months to 82.4 months

Outcome Measure Data

Analysis Population Description

Eligible and treated

Arm/Group Title	GEM+CIS+IMRT
Arm/Group Description	Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
Measure Participants	53
Number (90% Confidence Interval) [percentage of participants]	75 141.5%

Adverse Events

Time Frame	During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
Arm/Group Title	GEM+CIS+IMRT
Arm/Group Description	Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
All Cause Mortality
	GEM+CIS+IMRT
	Affected / at Risk (%)	# Events
Total	1/53 (1.9%)
Serious Adverse Events
	GEM+CIS+IMRT
	Affected / at Risk (%)	# Events
Total	24/53 (45.3%)
Blood and lymphatic system disorders
Anemia	1/53 (1.9%)
Febrile Neutropenia	3/53 (5.7%)
Cardiac disorders
Ventricular Tachycardia	1/53 (1.9%)
Gastrointestinal disorders
Diarrhea	2/53 (3.8%)
Gastrointestinal Pain	1/53 (1.9%)
Nausea	2/53 (3.8%)
General disorders
Sudden Death Nos	1/53 (1.9%)
Infections and infestations
Skin Infection	1/53 (1.9%)
Sepsis	1/53 (1.9%)
Lung Infection	1/53 (1.9%)
Injury, poisoning and procedural complications
Vascular Access Complication	1/53 (1.9%)
Fracture	1/53 (1.9%)
Investigations
Platelet Count Decreased	2/53 (3.8%)
Lymphocyte Count Decreased	1/53 (1.9%)
White Blood Cell Decreased	2/53 (3.8%)
Metabolism and nutrition disorders
Hypomagnesemia	2/53 (3.8%)
Hypokalemia	1/53 (1.9%)
Dehydration	2/53 (3.8%)
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb	1/53 (1.9%)
Nervous system disorders
Seizure	1/53 (1.9%)
Dizziness	1/53 (1.9%)
Reproductive system and breast disorders
Reproductive System And Breast Disorders - Other	1/53 (1.9%)
Other (Not Including Serious) Adverse Events
	GEM+CIS+IMRT
	Affected / at Risk (%)	# Events
Total	53/53 (100%)
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other	9/53 (17%)
Anemia	42/53 (79.2%)
Febrile Neutropenia	3/53 (5.7%)
Cardiac disorders
Atrial Fibrillation	2/53 (3.8%)
Mobitz Type I	1/53 (1.9%)
Supraventricular Tachycardia	1/53 (1.9%)
Sinus Bradycardia	2/53 (3.8%)
Palpitations	3/53 (5.7%)
Sinus Tachycardia	5/53 (9.4%)
Chest Pain - Cardiac	1/53 (1.9%)
Ear and labyrinth disorders
Tinnitus	4/53 (7.5%)
Eye disorders
Blurred Vision	2/53 (3.8%)
Floaters	1/53 (1.9%)
Gastrointestinal disorders
Enterocolitis	1/53 (1.9%)
Dysphagia	3/53 (5.7%)
Dyspepsia	1/53 (1.9%)
Constipation	20/53 (37.7%)
Diarrhea	39/53 (73.6%)
Vomiting	21/53 (39.6%)
Bloating	2/53 (3.8%)
Small Intestinal Obstruction	1/53 (1.9%)
Anal Hemorrhage	1/53 (1.9%)
Abdominal Pain	5/53 (9.4%)
Proctitis	3/53 (5.7%)
Mucositis Oral	2/53 (3.8%)
Lower Gastrointestinal Hemorrhage	1/53 (1.9%)
Gastrointestinal Disorders - Other	3/53 (5.7%)
Anal Pain	3/53 (5.7%)
Gingival Pain	1/53 (1.9%)
Abdominal Distension	1/53 (1.9%)
Nausea	38/53 (71.7%)
Gastroesophageal Reflux Disease	1/53 (1.9%)
Rectal Pain	2/53 (3.8%)
Hemorrhoidal Hemorrhage	1/53 (1.9%)
Hemorrhoids	4/53 (7.5%)
Flatulence	1/53 (1.9%)
General disorders
General Disorders And Administration Site Conditio	5/53 (9.4%)
Pain	9/53 (17%)
Malaise	2/53 (3.8%)
Localized Edema	3/53 (5.7%)
Non-Cardiac Chest Pain	2/53 (3.8%)
Edema Limbs	12/53 (22.6%)
Fatigue	42/53 (79.2%)
Fever	6/53 (11.3%)
Chills	2/53 (3.8%)
Immune system disorders
Allergic Reaction	1/53 (1.9%)
Infections and infestations
Infections And Infestations - Other	5/53 (9.4%)
Vulval Infection	2/53 (3.8%)
Skin Infection	2/53 (3.8%)
Sinusitis	1/53 (1.9%)
Sepsis	1/53 (1.9%)
Hepatitis Viral	1/53 (1.9%)
Vaginal Infection	4/53 (7.5%)
Urinary Tract Infection	13/53 (24.5%)
Injury, poisoning and procedural complications
Vascular Access Complication	1/53 (1.9%)
Fall	1/53 (1.9%)
Dermatitis Radiation	35/53 (66%)
Burn	1/53 (1.9%)
Bruising	1/53 (1.9%)
Investigations
Investigations - Other	2/53 (3.8%)
Weight Loss	5/53 (9.4%)
Platelet Count Decreased	38/53 (71.7%)
Lymphocyte Count Decreased	7/53 (13.2%)
Creatinine Increased	8/53 (15.1%)
Neutrophil Count Decreased	31/53 (58.5%)
Blood Bilirubin Increased	1/53 (1.9%)
White Blood Cell Decreased	41/53 (77.4%)
Aspartate Aminotransferase Increased	3/53 (5.7%)
Alkaline Phosphatase Increased	6/53 (11.3%)
Alanine Aminotransferase Increased	4/53 (7.5%)
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders - Other	1/53 (1.9%)
Hypophosphatemia	4/53 (7.5%)
Hyponatremia	15/53 (28.3%)
Hypomagnesemia	25/53 (47.2%)
Hypokalemia	19/53 (35.8%)
Hypoglycemia	1/53 (1.9%)
Hypocalcemia	13/53 (24.5%)
Hypoalbuminemia	18/53 (34%)
Hypernatremia	1/53 (1.9%)
Hyperkalemia	4/53 (7.5%)
Hyperglycemia	13/53 (24.5%)
Hypercalcemia	1/53 (1.9%)
Dehydration	7/53 (13.2%)
Anorexia	17/53 (32.1%)
Musculoskeletal and connective tissue disorders
Pain In Extremity	6/53 (11.3%)
Myalgia	3/53 (5.7%)
Muscle Weakness Lower Limb	2/53 (3.8%)
Generalized Muscle Weakness	5/53 (9.4%)
Back Pain	3/53 (5.7%)
Arthralgia	3/53 (5.7%)
Flank Pain	1/53 (1.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain	3/53 (5.7%)
Nervous system disorders
Seizure	1/53 (1.9%)
Presyncope	1/53 (1.9%)
Peripheral Sensory Neuropathy	7/53 (13.2%)
Paresthesia	1/53 (1.9%)
Headache	10/53 (18.9%)
Dysgeusia	5/53 (9.4%)
Dizziness	4/53 (7.5%)
Cognitive Disturbance	1/53 (1.9%)
Psychiatric disorders
Insomnia	7/53 (13.2%)
Depression	6/53 (11.3%)
Delirium	1/53 (1.9%)
Confusion	1/53 (1.9%)
Anxiety	2/53 (3.8%)
Agitation	1/53 (1.9%)
Renal and urinary disorders
Urine Discoloration	1/53 (1.9%)
Urinary Urgency	5/53 (9.4%)
Urinary Tract Obstruction	2/53 (3.8%)
Urinary Retention	3/53 (5.7%)
Urinary Incontinence	7/53 (13.2%)
Urinary Tract Pain	12/53 (22.6%)
Urinary Frequency	15/53 (28.3%)
Proteinuria	1/53 (1.9%)
Hematuria	4/53 (7.5%)
Cystitis Noninfective	2/53 (3.8%)
Chronic Kidney Disease	1/53 (1.9%)
Bladder Spasm	3/53 (5.7%)
Reproductive system and breast disorders
Vaginal Pain	11/53 (20.8%)
Vaginal Hemorrhage	7/53 (13.2%)
Perineal Pain	8/53 (15.1%)
Pelvic Pain	5/53 (9.4%)
Vaginal Discharge	9/53 (17%)
Vaginal Inflammation	1/53 (1.9%)
Genital Edema	1/53 (1.9%)
Respiratory, thoracic and mediastinal disorders
Hypoxia	1/53 (1.9%)
Dyspnea	9/53 (17%)
Cough	3/53 (5.7%)
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other	6/53 (11.3%)
Skin Ulceration	3/53 (5.7%)
Rash Acneiform	2/53 (3.8%)
Pruritus	6/53 (11.3%)
Pain Of Skin	5/53 (9.4%)
Rash Maculo-Papular	3/53 (5.7%)
Nail Loss	1/53 (1.9%)
Erythroderma	1/53 (1.9%)
Alopecia	6/53 (11.3%)
Surgical and medical procedures
Surgical And Medical Procedures - Other	1/53 (1.9%)
Vascular disorders
Thromboembolic Event	6/53 (11.3%)
Superficial Thrombophlebitis	2/53 (3.8%)
Lymphedema	1/53 (1.9%)
Hypotension	1/53 (1.9%)
Hypertension	8/53 (15.1%)
Hot Flashes	3/53 (5.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.