Perfusion CT in Predicting Outcomes in Ovarian, Fallopian, or Peritoneal Cancer With Bevacizumab

Recurrent Ovarian Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03412630
• Other study ID #: EAE161
• Secondary ID: NCI-2017-01029EA
• Status: Terminated
• Phase: N/A
• Start date: December 13, 2018
• Est. completion date: July 22, 2020

Study information

• Verified date: November 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 22, 2020
• Est. primary completion date: March 19, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Recurrence
• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma

Intervention

Radiation:
• Computed Tomography Perfusion Imaging
Undergo computed tomography perfusion imaging

Locations

Country	Name	City	State
United States	ECOG-ACRIN Cancer Research Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
ECOG-ACRIN Cancer Research Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	The PFS of patients with increased tumor blood flow (BF) from T0 to T1 will be compared with that of patients with decreased tumor BF from T0 to T1. Kaplan-Meier survival curves will be generated, and a two-sided log-rank test will be used to compare PFS between the two groups.	Time to progression or death from the T1 scan, assessed up to 18 months
Secondary	Objective Response Rate	Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1.	Up to 18 months