Clinical trial NCT00002478: Etoposide in Treating Patients With Advanced Ovarian or Cervical Cancer
Official title: Phase II Study of Prolonged Oral VP-16 for Advanced Ovarian Epithelial and Cervical Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cervical Cancer
Ovarian Cancer
Keywords: recurrent cervical cancer
recurrent ovarian epithelial cancer
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-09
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of etoposide in treating patients who have refractory, recurrent, or metastatic ovarian or cervical cancer.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Comprehensive Cancer Center
state: Alabama
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Washington
country: United States
facility: Vincent T. Lombardi Cancer Research Center, Georgetown University
state: District of Columbia
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital - Atlanta
state: Georgia
city: Honolulu
country: United States
facility: MBCCOP - Hawaii
state: Hawaii
city: Chicago
country: United States
facility: Rush-Presbyterian-St. Luke's Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Lexington
country: United States
facility: Albert B. Chandler Medical Center, University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Oncology Center
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: CCOP - Ann Arbor Regional
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Camden
country: United States
facility: Cooper Hospital/University Medical Center
state: New Jersey
city: Albany
country: United States
facility: Cancer Center of Albany Medical Center
state: New York
city: Brooklyn
country: United States
facility: State University of New York Health Science Center at Brooklyn
state: New York
city: Rochester
country: United States
facility: University of Rochester Cancer Center
state: New York
city: Stony Brook
country: United States
facility: State University of New York Health Sciences Center - Stony Brook
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, UNC
state: North Carolina
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Barrett Cancer Center, The University Hospital
state: Ohio
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital - Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma College of Medicine
state: Oklahoma
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
city: Dallas
country: United States
facility: Simmons Cancer Center - Dallas
state: Texas
city: Charlottesville
country: United States
facility: Cancer Center, University of Virginia HSC
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Tacoma
country: United States
facility: Tacoma General Hospital
state: Washington
Study officials:
affiliation: University Hospitals Seidman Cancer Center
name: Peter G. Rose, MD
role: STUDY_CHAIR
References:
citation: Rose PG, Blessing JA, Buller RE, Mannel RS, Webster KD. Prolonged oral etoposide in recurrent or advanced non-squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study. Gynecol Oncol. 2003 May;89(2):267-70. doi: 10.1016/s0090-8258(03)00079-9.
citation: Rose PG, Blessing JA, Mayer AR, Homesley HD. Prolonged oral etoposide as second-line therapy for platinum-resistant and platinum-sensitive ovarian carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 1998 Feb;16(2):405-10. doi: 10.1200/JCO.1998.16.2.405.
citation: Kudelka A, ed.: A phase II study of prolonged oral VP-16 in women with refractoy epithelial ovarian carcinoma. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-888, 276, 1994.