Brief Title
Computed Tomography Perfusion Imaging in Predicting Outcomes in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Receiving Bevacizumab
Official Title
Perfusion CT to Predict Progression-Free Survival and Response Rate in Bevacizumab Treatment of Platinum-Resistant Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Carcinoma
Brief Summary
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. 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.
Detailed Description
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.
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
(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.
TERTIARY OBJECTIVES:
I. In the subset of patients with multiple, eligible perfusion target lesions within the CT
imaging volume, 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. In a subset of patients, measure the reliability of perfusion CT parameters by analyzing
the same perfusion imaging dataset using different readers and different post-processing
software.
OUTLINE:
Patients undergo computed tomography perfusion imaging at baseline and on day 15 after
initiation of standard of care bevacizumab treatment and before the second dose.
After completion of study, patients are followed up every 8 weeks for up to 18 months.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression free survival (PFS)
Secondary Outcome
Objective response rate
Condition
Recurrent Fallopian Tube Carcinoma
Intervention
Computed Tomography Perfusion Imaging
Study Arms / Comparison Groups
Diagnostic (computed tomography perfusion imaging)
Description: Patients undergo computed tomography perfusion imaging at baseline and on day 15 after initiation of standard of care bevacizumab treatment and before the second dose.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
186
Start Date
February 14, 2018
Completion Date
March 31, 2024
Primary Completion Date
March 31, 2020
Eligibility Criteria
Inclusion Criteria:
- REGISTRATION TO STEP 0
- Patient must have epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Patients with non-epithelial 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, pegylated liposomal doxorubicin (PLD), or topotecan 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
- Patient must demonstrate an Eastern Cooperative Oncology Group (ECOG) performance
status of 0-2
- Patient must not have undergone therapy with any anti-VEGF drug within previous 6
months
- 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
- Patient must not have contraindication to iodinated contrast
- REGISTRATION TO STEP 1
- Patient must be evaluable using Response Evaluation Criteria in Solid Tumors (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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Susanna Lee, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03412630
Organization ID
EAE161
Secondary IDs
NCI-2017-01029
Responsible Party
Sponsor
Study Sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Susanna Lee, Principal Investigator, ECOG-ACRIN Cancer Research Group
Verification Date
July 2019