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| Sponsored by: |
Endocyte |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003763 |
Purpose
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 | Intervention |
|---|---|
|
Ovarian Cancer |
Drug: indium In 111 folic acid Procedure: radionuclide imaging |
| Study Type: | Interventional |
| Study Design: | Diagnostic |
| Official Title: | A Study to Determine the Ability of Folate Conjugates to Target Folate Receptors in Ovarian Cancer Tumors |
| Study Start Date: | January 1999 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5265 | |
| United States, Missouri | |
| Washington University - St. Louis | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | David M. Gershenson, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000066889, ENDOCYTE-EC.OV.53.958, ENDOCYTE-96-286, ENDOCYTE-98-0409 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003763 |
| Health Authority: | United States: Federal Government |
|
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 cancer Ovarian Neoplasms Gonadal Disorders Malignant mesenchymal tumor Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Ovarian epithelial cancer Recurrence Soft tissue sarcomas Folic Acid Genital Diseases, Female Sarcoma Endocrinopathy Endocrine Gland Neoplasms |
|
Neoplasms Vitamin B Complex Neoplasms by Site Hematinics Therapeutic Uses Growth Substances |
Vitamins Hematologic Agents Physiological Effects of Drugs Micronutrients Pharmacologic Actions Adnexal Diseases |
