Clinical Trial: NCT01595061 - My Cancer Genome

NCT01595061

Description:

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.

Related Conditions:

Vulvar Squamous Cell Carcinoma

Recruiting Status:

Active, not recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT01595061

Trial Eligibility

Document

Title

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

Clinical Trial IDs

ORG STUDY ID: GOG-0279
SECONDARY ID: NCI-2012-01964
SECONDARY ID: CDR0000732793
SECONDARY ID: GOG-0279
SECONDARY ID: GOG-0279
SECONDARY ID: U10CA180868
SECONDARY ID: U10CA027469
NCT ID: NCT01595061

Conditions

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

Interventions

Drug	Synonyms	Arms
Cisplatin	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	Treatment (IMRT, gemcitabine, cisplatin, surgery)
Gemcitabine Hydrochloride	dFdCyd, Difluorodeoxycytidine Hydrochloride, FF 10832, FF-10832, FF10832, Gemcitabine HCI, Gemzar, LY-188011, LY188011	Treatment (IMRT, gemcitabine, cisplatin, surgery)

Purpose

Detailed Description

      PRIMARY OBJECTIVES:

      I. 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:

      I. 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.

      II. 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.

      III. 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.

Trial Arms

Name	Type	Description	Interventions
Treatment (IMRT, gemcitabine, cisplatin, surgery)	Experimental	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.	Cisplatin Gemcitabine Hydrochloride

Eligibility Criteria

        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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	Female
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Complete pathologic response evaluated as the frequency of complete clinical and pathologic response after primary therapy
Time Frame:	6 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	Complete clinical response, defined as no clinical/radiographic evidence of primary disease (vulvar or groin) following chemo-radiation therapy
Time Frame:	6 weeks
Safety Issue:
Description:

Measure:	Incidence and severity of adverse effects tabulated based on the Common Terminology Criterial for Adverse Events (CTCAE) v 4.0
Time Frame:	Up to 5 years
Safety Issue:
Description:	Maximum grade of treatment related adverse effects will be tabulated based CTCAE v 4.0 grading system.

Measure:	Progression-free survival (PFS)
Time Frame:	From start of protocol therapy to date of reappearance of disease or date of last contact, assessed up to 5 years
Safety Issue:
Description:	Product-limit estimates according to the method of Kaplan and Meier will be calculated to assess duration of PFS among the entire study cohort and by response status.

Measure:	Site(s) of disease recurrence/relapse
Time Frame:	Up to 5 years
Safety Issue:
Description:	Site(s) of first disease recurrence will be classified as: local (vagina or vulva), loco-regional (within the pelvic) or distant and tabulated by response status.

Measure:	Overall survival (OS)
Time Frame:	From start of protocol therapy to death or, for living patients, the date of last contact, assessed up to 5 years
Safety Issue:
Description:	Product-limit estimates according to the method of Kaplan and Meier will be calculated to assess duration of OS among the entire study cohort and by response status.

Measure:	Treatment compliance, including treatment span, incidence and duration of treatment delay, reasons for delays, chemotherapy dose, radiation dose and reasons for dose level reductions
Time Frame:	Up to 5 years
Safety Issue:
Description:

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	Gynecologic Oncology Group

Last Updated

October 22, 2020

Clinical Trials /

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