Phase II Clinical Trial of PLX038 in Patients With Platinum-Resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
This phase II trial tests whether pegylated SN-38 conjugate PLX038 (PLX038) works to shrink tumors in patients with ovarian, primary peritoneal, and fallopian tube cancers that has spread from where it first started (primary site) to other places in the body (metastatic). PLX038 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
• Age \>= 18 years NOTE: Because no dosing or adverse event data are currently available on the use of PLX038 in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
• Histological confirmed high grade serous ovarian cancer consistent with ovarian, fallopian tube, or primary peritoneal carcinoma (NOTE: Any of these diseases are referred to in this protocol as ovarian cancer)
• Recurrent high grade serous ovarian cancer that was initially platinum sensitive (i.e., had at least one platinum-free interval of at least 6 months before progression) is now platinum resistant
• No more than one prior line of therapy for platinum resistant disease. NOTE: Prior poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy is allowed
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Disease that is amenable to two biopsies
• Life expectancy greater \>= 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Hemoglobin \>= 8.0 g/dL (obtained =\< 28 days prior to registration)
• Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 28 days prior to registration)
• Platelet count \>= 100,000/mm\^3 (obtained =\< 28 days prior to registration)
• Total bilirubin \>= 1.5 x upper limit of normal (ULN) (obtained =\< 28 days prior to registration)
• Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 3 x ULN (=\< 5 x ULN for patients with liver involvement) (obtained =\< 28 days prior to registration)
• Calculated creatinine clearance \>= 45 ml/min using the Cockcroft-Gault formula (obtained =\< 28 days prior to registration)
• Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
• Provide written informed consent
• Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
• Willingness to provide mandatory blood specimens for correlative research
• Willingness to provide mandatory tissue specimens for correlative research