Computed Tomography Perfusion Imaging in Predicting Outcomes in Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Receiving Bevacizumab and Paclitaxel

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Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • REGISTRATION TO STEP 0
  • Patient must have epithelial ovarian, fallopian tube, or primary peritoneal cancer; this includes high-grade serous ovarian cancer, endometroid, clear cell, mixed epithelial, undifferentiated carcinoma, transitional cell carcinoma histologies * Patients with carcinosarcoma, non-epithelial, low grade tumors, or tumors with low malignant potential are excluded
  • Patient must have suspected platinum-resistant disease (disease progression =< 6 months of platinum therapy)
  • Patient must be expected to undergo therapy with bevacizumab in combination with paclitaxel at recommended standard of care doses if suspected recurrence is confirmed with imaging
  • Patient must be able and willing to provide written informed consent
  • Patient must have a life expectancy of >= 3 months
  • Patient must have adequate bone marrow, coagulation, renal, and hepatic function; estimated glomerular filtration rate (eGFR) calculation >= 60 mL/min/1.73 m^2 (within 28 days of screening CT submission)
  • Patient must demonstrate an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Patient must not have undergone therapy with any VEGF monoclonal antibodies in the last twelve weeks; patient must not have received any small molecule anti-VEGF drug within the previous 4 weeks
  • Patient must not have undergone major surgery or radiotherapy to the pelvis or abdomen within previous 4 weeks
  • Patients must not have known contraindications to bevacizumab, including but not limited to abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess, thrombotic or hemorrhagic disorders, uncontrolled hypertension or active clinically significant cardiovascular disease, non-healing wound, ulcer, or bone fracture within previous 4 weeks
  • Patient must not have untreated or symptomatic central nervous system (CNS) metastasis
  • Patient must not have another active (within past 3 years) or concurrent malignancy; resected basal cell skin cancer is allowed within past 3 years
  • Patient must not have contraindication to iodinated contrast
  • REGISTRATION TO STEP 1
  • Patient must be evaluable using RECIST 1.1 criteria
  • Patient must have perfusion CT target lesion (e.g., >= 1 cm in both the long and short axis, at least one half of the tumor appears enhancing and solid on a contrast-enhanced scan or has an attenuation of >= 10 Hounsfield unit [HU] on the unenhanced CT scan) on a contrast-enhanced conventional CT
  • Conventional chest abdomen and pelvis CT images demonstrating recurrent tumor must be submitted within 21 days from acquisition to the American College of Radiology (ACR) Core Lab
  • Eligibility of a perfusion CT target lesion must be confirmed by the ACR Core Lab prior to study enrollment and the T0 perfusion CT scan

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 205-934-0220
Email: tmyrick@uab.edu

Arizona

Tucson
The University of Arizona Medical Center-University Campus
Status: Active
Contact: Site Public Contact
Phone: 520-626-9008

Minnesota

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Paul
United Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: Active
Contact: Site Public Contact
Phone: 215-955-6084

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Diagnostic

Lead Organization

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Susanna I. Lee

Trial IDs

Primary ID EAE161
Secondary IDs NCI-2017-01029
Clinicaltrials.gov ID NCT03412630