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NCT00003523 Clinical Trial

Aminocamptothecin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Cancer of the Peritoneum

Ovarian Cancer Clinical Trial

Official title:
Evaluation of Aminocamptothecin (9-AC, NSC #603071) in Recurrent, Platinum Resistant and Refractory Ovarian Cancer and Primary Peritoneal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00003523
Other study ID # CDR0000066567
Secondary ID GOG-126I
Status Completed
Phase Phase 2
First received September 11, 2000
Last updated June 20, 2013
Start date January 1999
Est. completion date October 2007

Study information
Verified date June 2005
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
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 aminocamptothecin in treating patients with recurrent or refractory ovarian epithelial cancer or primary cancer of the peritoneum.

Description:

OBJECTIVES: I. Estimate the antitumor activity of aminocamptothecin colloidal dispersion in patients with platinum-resistant recurrent or refractory ovarian cancer or primary peritoneal carcinoma who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of aminocamptothecin colloidal dispersion in this patient population.

OUTLINE: Patients receive aminocamptothecin colloidal dispersion IV over 120 hours weekly for two of every three weeks. Courses are repeated every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 23-56 patients will be accrued for this study within 5-12 months.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 13 Years and older
Eligibility DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent ovarian epithelial cancer or primary peritoneal carcinoma Progressive disease on platinum-based treatment alone or in combination Two prior treatment regimens allowed only if other regimen was paclitaxel OR recurrence within 6 months of chemotherapy Measurable disease Not eligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: 13 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Other: No significant infection Not pregnant Fertile patients must use effective contraception At least 5 years since prior malignancy; no prior chemotherapy or radiotherapy for that malignancy No concurrent malignancy other than non-melanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No prior treatment with aminocamptothecin Endocrine therapy: At least 4 weeks since prior endocrine therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to site(s) of measurable disease used on this trial No prior radiotherapy to more than 25% of marrow-bearing areas Surgery: At least 4 weeks since prior surgery

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• aminocamptothecin colloidal dispersion

Locations
Country Name City State
Canada Tom Baker Cancer Center - Calgary Calgary Alberta
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 CCOP - Atlanta Regional Atlanta Georgia
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 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 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 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 Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Duke Comprehensive Cancer Center Durham North Carolina
United States CCOP - Evanston Evanston Illinois
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 AFB 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 Brookview Research, Inc. Nashville Tennessee
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 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 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 - Sooner State 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 Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem North Carolina
United States University of Massachusetts Memorial Medical Center Worcester Massachusetts

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, Waggoner S, Schilder J, Sorosky J, Bloss J, Schilder R. Phase II evaluation of 9-aminocamptothecin (9-AC, NSC #603071) in platinum-resistant ovarian and primary peritoneal carcinoma: a Gynecologic Oncology Group Study. Gynecol Onco — View Citation

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