Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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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 |
| Study Start Date: | January 2003 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
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 |
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
Hide Study 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 | |
| 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