Intravenous Weekly Topotecan In Subjects With Recurrent Or Persistent Endometrial Cancer

Subject must have at least one measurable lesion according to GOG-modified RECIST criteria.

• Measurable disease must be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpation, plain X-ray, CT and MRI, or ≥10 mm when measured by spiral CT.
• Measurable disease found on chest X-ray must be confirmed with CT or MRI. Either CT or MRI must be used throughout the study to further evaluate these lesions.
• The same diagnostic method (CT, MRI, X-ray or physical exam) used to evaluate disease, must be used throughout the study to consistently evaluate lesions.
• Palpable tumor masses that cannot be evaluated by CT or MRI scan should be evaluated by ultrasound or confirmed by biopsy.
• Evaluable disease (measurable or non-measurable) may be in a field of prior radiation provided that at least six weeks have elapsed since receiving radiation and disease progression is clearly documented by radiographic study. It is preferential for the target lesion to be located outside an irradiated field.
• Non-measurable disease is defined as all other lesions, including small lesions (longest diameter <20 mm with conventional techniques or <10 mm with spiral CT scan).

Subject of childbearing potential must be practicing adequate contraception [e.g., oral contraceptives, diaphragm plus spermicide, or intrauterine device (IUD)] or show documented complete abstinence from intercourse for at least three months prior to study start. The same contraceptive method should be used throughout the study and continue for at least four weeks after the end of the study. A subject will be considered of childbearing potential if not surgically sterile or post-menopausal (i.e., documented absence of menses for one year prior to entry into the study). 14. Subject must have screening laboratory criteria as follows:

• Hemoglobin ≥ 9.0 g/dL.
• Neutrophils ≥ 1,500/mm³ [≥1.5 x 10^9/L].
• Platelets ≥ 100,000/mm³ [≥100.0 x 10^9/L].
• Creatinine ≤ upper limit of normal (ULN) or creatinine clearance (Clcreat) ≥ 60mL/min.
• Creatinine clearance should be calculated using the Cockcroft-Gault formula: Clcreat (mL/min) = (140-age [yr] x body wt [kg] x 0.85 72 x serum creatinine [mg/dL] OR Clcreat (mL/min) = 1.05 x (140-age [yr] x body wt [kg] serum creatinine [μmol/L]
• Serum bilirubin within normal limits.
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase < 2xULN if liver metastases are absent by abdominal CT or MRI or < 5xULN if liver metastases are present.