Primary Peritoneal Cavity Cancer Clinical Trial
Official title:
Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer
This phase II trial is studying how well EF5 works in finding oxygen in tumor cells of patients who are undergoing surgery or biopsy for cervical, endometrial, or ovarian epithelial cancer. Diagnostic procedures using the drug EF5 to find oxygen in tumor cells may help in planning cancer treatment
Status | Completed |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | September 2005 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed* diagnosis of 1 of the following: - Cervical cancer - Ovarian epithelial cancer - Endometrial cancer - Peritoneal cavity cancer - Requires surgery or biopsy for diagnosis or as standard initial treatment for the tumor - Performance status - ECOG 0-2 - WBC = 2,000/mm^3 - Platelet count = 100,000/mm^3 - Bilirubin normal - Creatinine normal - Creatinine clearance = 60 mL/min - No significant cardiac condition that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 month after study participation - Weight = 130 kg - No other significant medical condition that would preclude study participation - No scheduled chemotherapy for the tumor within the past 3 months - No scheduled radiotherapy to the tumor within the past 3 months - No other concurrent investigational agents |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Abramson Cancer Center of The University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of EF5 binding | The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient. | Baseline | No |
Primary | Hemoglobin level | The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient. | Baseline | No |
Primary | Time to progression | Analyzed using Kaplan-Meier procedures. | Up to 1 year | No |
Primary | Time to recurrence | Analyzed using Kaplan-Meier procedures. | Up to 1 year | No |
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