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A Study to Determine the Ability of Folate Conjugates to Target Folate Receptors in Ovarian Cancer Tumors


N/A
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

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Trial Information

A Study to Determine the Ability of Folate Conjugates to Target Folate Receptors in Ovarian Cancer Tumors


OBJECTIVES: I. Evaluate the effectiveness of folic acid conjugated with indium In 111 to
diagnose ovarian cancer and locate metastatic disease.

OUTLINE: This is a diagnostic study. Patients receive an injection of folic acid conjugated
with indium In 111. The patient then undergoes imaging studies at various time points (e.g.,
1, 4, and 24 hours). Patients then undergo exploratory surgery, the results of which are
then compared to the imaging studies.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Suspected ovarian cancer OR Recurrence of ovarian cancer
Scheduled for exploratory surgery

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3000/mm3 Granulocyte count at least 1500/mm3
Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no
greater than 2.0 mg/dL SGPT and SGOT no greater than 2 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 2 times ULN No acute hepatitis Renal: Creatinine no
greater than 1.4 mg/dL BUN no greater than 1.5 times ULN No known or suspected kidney
disease Cardiovascular: No history of congestive heart failure No unstable angina No
myocardial infarction within 6 months Other: Not pregnant or nursing No septicemia or
severe infection No medical condition that would preclude the administration of large
fluid volumes over a short period of time

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 months
since prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: At least
3 months since prior radiotherapy Surgery: See Disease Characteristics Other: At least 2
days since prior folic acid supplements At least 5 days since nonsteroidal
antiinflammatory medications

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

David M. Gershenson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066889

NCT ID:

NCT00003763

Start Date:

January 1999

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • ovarian stromal cancer
  • stage I ovarian germ cell tumor
  • stage II ovarian germ cell tumor
  • stage III ovarian germ cell tumor
  • stage IV ovarian germ cell tumor
  • recurrent ovarian germ cell tumor
  • borderline ovarian surface epithelial-stromal tumor
  • ovarian sarcoma
  • Ovarian Neoplasms

Name

Location
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Washington University - St. Louis St. Louis, Missouri  63110