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

Purpose

RATIONALE: 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.

PURPOSE: 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.

Condition	Intervention	Phase
Vulvar Cancer	Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: biopsy Procedure: therapeutic conventional surgery Radiation: intensity-modulated radiation therapy	Phase 2

Study Type:	Interventional
Study Design:	Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Vulvar Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:

Complete pathologic response (pCR) evaluated as the frequency of complete clinical and pathologic response after primary therapy [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complete clinical response [ Designated as safety issue: No ]
Incidence and severity of adverse effects tabulated based on the Common Terminology Criterial for Adverse Events (CTCAE) v 4.0 [ Designated as safety issue: Yes ]
Progression-free survival (PFS) estimated according to the method of Kaplan and Meier [ Designated as safety issue: No ]
Overall survival (OS) estimated according to the method of Kaplan and Meier [ Designated as safety issue: No ]
Site(s) of disease recurrence/relapse classified as local (vagina or vulva), loco-regional (within the pelvic), or distant tabulated by response status [ Designated as safety issue: No ]
Treatment compliance [ Designated as safety issue: No ]

Estimated Enrollment:	52
Study Start Date:	August 2012
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595061

Show 39 Study Locations

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Neil S. Horowitz, MD

Dana-Farber/Brigham and Women's Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Gynecologic Oncology Group
ClinicalTrials.gov Identifier:	NCT01595061 History of Changes
Other Study ID Numbers:	GOG-0279, NCI-2012-01964
Study First Received:	May 8, 2012
Last Updated:	May 7, 2013
Health Authority:	United States: National Cancer Institutie

Keywords provided by Gynecologic Oncology Group:

squamous cell carcinoma of the vulva
stage IIIA vulvar cancer
stage IIIB vulvar cancer
stage IIIC vulvar cancer
stage IVA vulvar cancer

Additional relevant MeSH terms:

Vulvar Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases
Carcinoma
Carcinoma, Squamous Cell
Genital Diseases, Female
Gemcitabine
Cisplatin

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 16, 2013