RATIONALE: Diagnostic procedures using the drug radiolabeled folic acid and imaging may be effective in detecting ovarian cancer.

PURPOSE: Diagnostic trial to study the effectiveness of radiolabeled folic acid plus imaging in detecting ovarian cancer.

Condition

Treatment or Intervention

recurrent ovarian germ cell tumor recurrent ovarian epithelial cancer stage I ovarian epithelial cancer stage II ovarian germ cell tumor stage III ovarian germ cell tumor stage II ovarian epithelial cancer stage IV ovarian germ cell tumor stage I ovarian germ cell tumor stage III ovarian epithelial cancer stage IV ovarian epithelial cancer ovarian stromal cancer ovarian low malignant potential tumor ovarian sarcoma

Drug: folic acid

Further Study Details: 

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

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Suspected ovarian cancer OR Recurrence of ovarian cancer
• Scheduled for exploratory surgery

--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

--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

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

Study chairs or principal investigators

David Marc Gershenson,  Study Chair,  Endocyte   

Study ID Numbers:  CDR0000066889; ENDOCYTE-EC.OV.53.958; ENDOCYTE-96-286; ENDOCYTE-98-0409
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003763
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08