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

Phase 2
Not Enrolling
Cervical Cancer, Ovarian Cancer

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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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter G. Rose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospitals Seidman Cancer Center


United States: Federal Government

Study ID:




Start Date:

June 1993

Completion Date:

Related Keywords:

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



University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
Stanford University Medical Center Stanford, California  94305-5408
University of Colorado Cancer Center Denver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown University Washington, District of Columbia  20007
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
MBCCOP - Hawaii Honolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Johns Hopkins Oncology Center Baltimore, Maryland  21287
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Cooper Hospital/University Medical Center Camden, New Jersey  08103
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
University of Rochester Cancer Center Rochester, New York  14642
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Cancer Center, University of Virginia HSC Charlottesville, Virginia  22908
University of Washington Medical Center Seattle, Washington  98195-6043
Tacoma General Hospital Tacoma, Washington  98405