A Single-Center, Open-Label, Single-Arm, Phase I Study With Dose Expansion Cohort of Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer
This is an open-label, Phase 1 study with a dose expansion cohort of Sacituzumab Govitecan in Combination with Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer. The goal of the study is to determine the optimal dose of sacituzumab govitecan for use in combination with cisplatin for treatment of epithelial ovarian and endometrial cancers.
• Pathologic (histology or cytology) confirmed diagnosis of epithelial ovarian cancer or endometrial cancer
• Radiographic evidence of recurrent epithelial ovarian cancer (ovarian, fallopian tube, or primary peritoneal cancer) or endometrial cancer that is platinum-sensitive, defined as progression of disease beyond 6 months from the last dose of platinum-based chemotherapy
• Female, age ≥ 18 years
• World Health Organization (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
• Patient has measurable disease (at least one lesion that can be accurately assessed repeatedly by CT) as evidenced on pre-treatment baseline CT of Chest/Abdomen/Pelvis or PET/CT, or evaluable disease
• Adequate hematologic counts, as defined below, without transfusion or growth factor support within 2 weeks of study drug initiation:
‣ Hemoglobin ≥ 8.5 g/dL
⁃ Absolute neutrophil count ≥ 1500/mm3
⁃ Platelets ≥ 100,000/μL
• Adequate organ function as defined below:
‣ Total bilirubin ≤ 1.5 ULN
⁃ AST(SGOT)/ALT(SPGT) ≤ 2.5x ULN or ≤ 5 x ULN if known liver metastases
⁃ Serum albumin \> 3 g/dL
⁃ Creatinine clearance ≥ 50 mL/min per the Cockcroft-Gault equation
• Women of childbearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• o A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
⁃ Has not undergone a hysterectomy or bilateral oophorectomy; or
⁃ Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Ability to understand and the willingness to sign a written informed consent.