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Phase II Study of Prolonged Oral VP-16 for Advanced Ovarian Epithelial and Cervical Cancer


Phase 2
N/A
N/A
Not Enrolling
Female
Cervical Cancer, Ovarian Cancer

Thank you

Trial Information

Phase II Study of Prolonged Oral VP-16 for Advanced Ovarian Epithelial and Cervical Cancer


OBJECTIVES: I. Determine the efficacy of prolonged oral etoposide (VP-16) in patients with
advanced ovarian epithelial or cervical cancer. II. Evaluate the frequency and severity of
observed adverse effects in this patient population treated with prolonged oral VP-16.

OUTLINE: Patients receive etoposide by mouth once daily on days 1-21 every 4 weeks. Patients
with responding disease continue treatment for up to 12 months in the absence of disease
progression or unacceptable toxicity. Patients with stable disease continue treatment for up
to 6 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: If 4-6 responses are observed in the first 25 patients, an additional 15
patients will be entered. The estimated duration of the study is 8 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed recurrent or metastatic ovarian
epithelial or cervical cancer Tissue not accessible for biopsy Refractory to curative
therapy or established treatments and ineligible for higher priority GOG protocols
Measurable disease required, as follows: Lesion measurable by physical exam Lesion
bidimensionally measurable on sonogram or imaging Ascites/pleural effusion not measurable

PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at
least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelets at least
100,000/mm3 Hepatic: Bilirubin no more than 1.5 times normal AST no more than 3 times
normal Alkaline phosphatase no more than 3 times normal Renal: Creatinine no greater than
2.0 mg/dL Other: Body surface area at least 1 square meter No requirement for intravenous
hydration or nutritional support No significant infection No second malignancy other than
nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since anticancer therapy
Chemotherapy: No more than 1 prior chemotherapy trial No prior etoposide At least 3 weeks
since chemotherapy and recovered Endocrine therapy: At least 3 weeks since anticancer
therapy Radiotherapy: At least 3 weeks since radiotherapy Surgery: At least 3 weeks since
surgery and recovered

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter G. Rose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospitals Seidman Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000077078

NCT ID:

NCT00002478

Start Date:

June 1993

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Ovarian Cancer
  • recurrent cervical cancer
  • recurrent ovarian epithelial cancer
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms

Name

Location

University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
Stanford University Medical CenterStanford, California  94305-5408
University of Colorado Cancer CenterDenver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown UniversityWashington, District of Columbia  20007
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
MBCCOP - HawaiiHonolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
University of Rochester Cancer CenterRochester, New York  14642
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
University of Washington Medical CenterSeattle, Washington  98195-6043
Tacoma General HospitalTacoma, Washington  98405