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

NCT ID: NCT00003523

Last Updated: 2013-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ovarian Cancer Primary Peritoneal Cavity Cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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aminocamptothecin colloidal dispersion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

13 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role lead

Principal Investigators

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David S. Miller, MD

Role: STUDY_CHAIR

Simmons Cancer Center

Locations

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University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status

CCOP - Greater Phoenix

Phoenix, Arizona, United States

Site Status

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Site Status

Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status

Women's Cancer Center

Palo Alto, California, United States

Site Status

University of Colorado Cancer Center

Denver, Colorado, United States

Site Status

Vincent T. Lombardi Cancer Research Center, Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Emory University Hospital - Atlanta

Atlanta, Georgia, United States

Site Status

CCOP - Atlanta Regional

Atlanta, Georgia, United States

Site Status

MBCCOP - Hawaii

Honolulu, Hawaii, United States

Site Status

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Site Status

CCOP - Central Illinois

Decatur, Illinois, United States

Site Status

CCOP - Evanston

Evanston, Illinois, United States

Site Status

Indiana University Cancer Center

Indianapolis, Indiana, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, United States

Site Status

Johns Hopkins Oncology Center

Baltimore, Maryland, United States

Site Status

Medicine Branch

Bethesda, Maryland, United States

Site Status

Radiation Oncology Branch

Bethesda, Maryland, United States

Site Status

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

Site Status

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, United States

Site Status

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Keesler Medical Center - Keesler AFB

Keesler Air Force Base, Mississippi, United States

Site Status

CCOP - Kansas City

Kansas City, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

CCOP - Montana Cancer Consortium

Billings, Montana, United States

Site Status

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

Site Status

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Site Status

Cooper Hospital/University Medical Center

Camden, New Jersey, United States

Site Status

Cancer Center of Albany Medical Center

Albany, New York, United States

Site Status

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, United States

Site Status

North Shore University Hospital

Manhasset, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

University of Rochester Cancer Center

Rochester, New York, United States

Site Status

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, United States

Site Status

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, United States

Site Status

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Site Status

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, United States

Site Status

Ireland Cancer Center

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Cancer Center

Cleveland, Ohio, United States

Site Status

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

Site Status

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, United States

Site Status

CCOP - Sooner State

Tulsa, Oklahoma, United States

Site Status

CCOP - Columbia River Program

Portland, Oregon, United States

Site Status

Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Site Status

CCOP - Baptist Cancer Institute

Memphis, Tennessee, United States

Site Status

Brookview Research, Inc.

Nashville, Tennessee, United States

Site Status

Simmons Cancer Center - Dallas

Dallas, Texas, United States

Site Status

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

Tacoma General Hospital

Tacoma, Washington, United States

Site Status

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

Site Status

Countries

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United States Canada

References

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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 Oncol. 2005 Jan;96(1):67-71. doi: 10.1016/j.ygyno.2004.09.015.

Reference Type RESULT
PMID: 15589582 (View on PubMed)

Other Identifiers

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GOG-126I

Identifier Type: -

Identifier Source: secondary_id

CDR0000066567

Identifier Type: -

Identifier Source: org_study_id

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