Topotecan in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

Ovarian Cancer Clinical Trial

Official title:

Phase II Evaluation of Three-Day Topotecan (NSC 609699) in Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00005029
• Other study ID #: CDR0000067550
• Secondary ID: GOG-0146K
• Status: Terminated
• Phase: Phase 2
• First received: April 6, 2000
• Last updated: April 11, 2018
• Start date: February 2000

Study information

• Verified date: April 2018
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 topotecan in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.

Description:

OBJECTIVES: I. Determine the antitumor activity of topotecan in patients with recurrent platinum sensitive ovarian epithelial or primary peritoneal cancer. II. Determine the nature and degree of toxicity of this treatment regimen in these patients.

OUTLINE: Patients receive topotecan IV over 30 minutes on days 1-3. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 120 Years

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed recurrent ovarian epithelial or primary peritoneal carcinoma Bidimensionally measurable disease (ascites and pleural effusions not considered measurable) Platinum sensitive (defined as treatment free interval following response to platinum of greater than 6 months) One prior platinum based chemotherapy regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound required

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy:

Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least lower limit of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and alkaline phosphatase no greater that 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No active infection requiring antibiotics No neuropathy greater than grade 1 Not pregnant Negative pregnancy test Fertile patients must use effective contraception No prior malignancy within past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic or immunologic agents Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy Patients with no prior paclitaxel therapy may receive second regimen that includes paclitaxel No other prior or concurrent cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens No prior topotecan Endocrine therapy: At least one week since prior hormonal therapy for malignant tumor Prior and concurrent hormone replacement therapy allowed Radiotherapy: No prior or concurrent radiotherapy to target sites No prior radiotherapy to greater than 25% of bone marrow Recovered from prior radiotherapy Surgery: Recovered from prior surgery Other: No prior cancer treatment that contraindicates study

Related Conditions & MeSH terms

• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• topotecan hydrochloride

Locations

Country	Name	City	State
Canada	NCIC-Clinical Trials Group	Kingston	Ontario
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Cancer Center of Albany Medical Center	Albany	New York
United States	CCOP - Ann Arbor Regional	Ann Arbor	Michigan
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Johns Hopkins Oncology Center	Baltimore	Maryland
United States	Medicine Branch	Bethesda	Maryland
United States	Radiation Oncology Branch	Bethesda	Maryland
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama
United States	Tufts University School of Medicine	Boston	Massachusetts
United States	State University of New York Health Science Center at Brooklyn	Brooklyn	New York
United States	Cooper Hospital/University Medical Center	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cancer Center, University of Virginia HSC	Charlottesville	Virginia
United States	MBCCOP - University of Illinois at Chicago	Chicago	Illinois
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	CCOP - Central Illinois	Decatur	Illinois
United States	University of Colorado Cancer Center	Denver	Colorado
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	CCOP - Evanston	Evanston	Illinois
United States	CCOP - Greenville	Greenville	South Carolina
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Keesler Medical Center - Keesler AFB	Keesler Air Force Base	Mississippi
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	CCOP - Baptist Cancer Institute	Memphis	Tennessee
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Women's Cancer Center	Palo Alto	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	CCOP - Greater Phoenix	Phoenix	Arizona
United States	CCOP - Columbia River Program	Portland	Oregon
United States	University of Rochester Cancer Center	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Washington Medical Center	Seattle	Washington
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York
United States	Tacoma General Hospital	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center	Tulsa	Oklahoma
United States	Vincent T. Lombardi Cancer Research Center, Georgetown University	Washington	District of Columbia
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Brookview Research, Inc.	Winston-Salem	North Carolina
United States	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Miller DS, Blessing JA, Lentz SS, McMeekin DS. Phase II evaluation of three-day topotecan in recurrent platinum-sensitive ovarian carcinoma: a gynecologic oncology group study. Cancer. 2003 Oct 15;98(8):1664-9. — View Citation