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A Phase II Evaluation Of Karenitecin (IND #57250) In The Third-Line Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma


Phase 2
N/A
N/A
Not Enrolling
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Evaluation Of Karenitecin (IND #57250) In The Third-Line Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

John J. Kavanagh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000269898

NCT ID:

NCT00054119

Start Date:

January 2003

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
MBCCOP - HawaiiHonolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Tacoma General HospitalTacoma, Washington  98405
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Community Hospital of Los GatosLos Gatos, California  95032
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
University of Texas Medical BranchGalveston, Texas  77555-1329
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
Cooper University HospitalCamden, New Jersey  08103
Tufts - New England Medical CenterBoston, Massachusetts  02111
Barrett Cancer CenterCincinnati, Ohio  45267-0502
Fletcher Allen Health Care - Medical Center CampusBurlington, Vermont  05401
CCOP - M.D. Anderson Research BaseHouston, Texas  77030-4009
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
Gynecologic Oncology of Middle TennesseeNashville, Tennessee  37203
University of Houston College Of PharmacyHouston, Texas  77030