This phase II trial studies how well computed tomography perfusion imaging works in predicting outcomes in patients with ovarian, fallopian tube, or primary peritoneal cancer who are receiving bevacizumab and paclitaxel. Computed tomography perfusion imaging monitors the effects of the drug treatment on the blood flow to the tumor, and may help to predict whether a certain drug therapy is likely be successful in a patient with ovarian, fallopian tube, or primary peritoneal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03412630.
PRIMARY OBJECTIVES:
I. To evaluate whether those patients with an increase in perfusion computed tomography (CT) tumor blood flow (BF) from T0 to T1 demonstrate poorer progression-free survival (PFS) compared to those patients with a decrease in BF from T0 to T1, among platinum-resistant, recurrent ovarian cancer patients treated with bevacizumab in combination with paclitaxel.
SECONDARY OBJECTIVES:
I. To evaluate whether change in perfusion CT tumor BF from T0 to T1, as a continuous variable, is associated with PFS.
II. To evaluate whether changes in perfusion CT tumor blood volume (BV) or permeability surface product area (PS) from T0 to T1 are associated with PFS.
III. To evaluate whether changes in perfusion CT tumor BF, BV, or PS from T0 to T1 are associated with response rate according to the standard anatomic response evaluation criteria (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).
IV. To identify which combination of perfusion CT parameters, including tumor BF, BV, and PS, can serve to optimally distinguish patients in terms of PFS outcome.
V. To evaluate whether the association between change in perfusion CT parameters and treatment outcome (PFS or tumor response) is stable when analyzed with various commercially-available post-processing software.
EXPLORATORY OBJECTIVES:
I. In the subset of patients with multiple, eligible perfusion target lesions within the CT imaging volume, we will describe the variability of perfusion CT changes across different lesions within the same patient, and evaluate the impact of multiple target lesions on the association between change in perfusion CT parameters and PFS.
II. To evaluate the reliability of perfusion CT parameters by analyzing the same perfusion imaging dataset using different readers and different post-processing software.
III. To evaluate whether change in global vascular tumor burden (VTB) from T0 to T1 is associated with PFS, and with changes in BF, BV, or PS.
OUTLINE:
Patients undergo computed tomography perfusion imaging at baseline and on day 15 after initiation of standard of care bevacizumab and paclitaxel treatment and before the second dose of bevacizumab.
After completion of study, patients are followed up every 9 weeks for up to 18 months.
Lead OrganizationECOG-ACRIN Cancer Research Group
Principal InvestigatorSusanna I. Lee