Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054119
First received: February 5, 2003
Last updated: April 23, 2011
Last verified: September 2004
  Purpose

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 karenitecin in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based treatment.


Condition Intervention Phase
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: karenitecin
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation Of Karenitecin (IND #57250) In The Third-Line Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2003
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of karenitecin in patients with persistent or recurrent platinum-resistant ovarian epithelial or primary peritoneal cancer.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive karenitecin IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter .

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22 months.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial or primary peritoneal cancer

    • Recurrent or persistent disease
    • Platinum-resistant disease
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • At least 1 target lesion to assess response (tumors within a previously irradiated field are designated as non-target)
  • Ineligible for a higher priority GOG study or other phase II cytotoxic study for platinum-resistant disease

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • No myocardial infarction within the past 6 months
  • No cerebrovascular accident within the past 6 months
  • No transient ischemic attack within the past 6 months
  • No uncontrolled hypertension
  • No decompensated or uncontrolled chronic heart failure

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No neuropathy (sensory or motor) grade 2 or greater
  • No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
  • No active infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 3 weeks since prior biological or immunological agents

Chemotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy and recovered
  • No more than 2 prior cytotoxic chemotherapy regimens, with no more than 1 non-platinum, non-taxane regimen
  • No prior karenitecin or camptothecin analogue/derivative

Endocrine therapy

  • At least 1 week since prior hormonal therapy

    • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 25% of marrow-bearing areas

Surgery

  • Recovered from recent surgery

Other

  • At least 3 weeks since prior therapy directed at this malignancy
  • No prior anticancer therapy that would preclude study therapy
  • No concurrent amifostine or other protective reagents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054119

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1740
Community Hospital of Los Gatos
Los Gatos, California, United States, 95032
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612-3864
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Massachusetts
Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905-0001
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103-1489
United States, New York
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
North Shore University Hospital
Manhasset, New York, United States, 11030
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11794-8091
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1065
United States, Ohio
Barrett Cancer Center
Cincinnati, Ohio, United States, 45267-0526
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Ireland Cancer Center
Cleveland, Ohio, United States, 44106
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001-3788
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-2233
United States, Tennessee
Gynecologic Oncology of Middle Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75390-9032
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
CCOP - M.D. Anderson Research Base
Houston, Texas, United States, 77030-4009
University of Houston College Of Pharmacy
Houston, Texas, United States, 77030
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Vermont
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Tacoma General Hospital
Tacoma, Washington, United States, 98405
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6188
Australia, New South Wales
Australia New Zealand Gynaecological Oncology Trials Group
Camperdown, New South Wales, Australia, 1450
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Japan
Kagoshima City Hospital
Kagoshima City, Japan, 892-8580
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
United Kingdom
University of Birmingham
Birmingham, England, United Kingdom, B15 2TT
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: John J. Kavanagh, MD M.D. Anderson Cancer Center
Investigator: Judith A. Smith, PharmD, BCOP M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00054119     History of Changes
Other Study ID Numbers: CDR0000269898, GOG-0186D, BIONUM-KTN22307
Study First Received: February 5, 2003
Last Updated: April 23, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 23, 2013