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


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

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David S. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066567

NCT ID:

NCT00003523

Start Date:

January 1999

Completion Date:

October 2007

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

Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown University Washington, District of Columbia  20007
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
MBCCOP - Hawaii Honolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Johns Hopkins Oncology Center Baltimore, Maryland  21287
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Cooper Hospital/University Medical Center Camden, New Jersey  08103
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
University of Rochester Cancer Center Rochester, New York  14642
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of Washington Medical Center Seattle, Washington  98195-6043
Tacoma General Hospital Tacoma, Washington  98405
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
Women's Cancer Center Palo Alto, California  94304
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Baptist Cancer Institute Memphis, Tennessee  38117
Brookview Research, Inc. Nashville, Tennessee  37203
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Evanston Evanston, Illinois  60201
North Shore University Hospital Manhasset, New York  11030
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
CCOP - Sooner State Tulsa, Oklahoma  74136
Medicine Branch Bethesda, Maryland  20892
Radiation Oncology Branch Bethesda, Maryland  20892