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

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

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