Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
Conditions
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.
Interventions
Undergo computed tomography perfusion imaging
Sponsors
National Cancer Institute (NCI)
ECOG-ACRIN Cancer Research Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Time to progression or death from the T1 scan, assessed up to 18 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | Up to 18 months | Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. |
Countries
United States
Participant flow
Recruitment details
The first patient was accrued on December 13, 2018.
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic (Computed Tomography Perfusion Imaging) 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.
Computed Tomography Perfusion Imaging: Undergo computed tomography perfusion imaging | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | — | Diagnostic (Computed Tomography Perfusion Imaging) |
|---|---|---|
| Age, Continuous | — years | — |
| Sex: Female, Male Female | — | 0 Participants |
| Sex: Female, Male Male | — | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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 frame: Time to progression or death from the T1 scan, assessed up to 18 months
Population: Analysis not performed due to lack of data. Only 1 participant was accrued and available for analysis. This is insufficient for any meaningful statistical analysis and thus no analyses were performed. To comply with HIPAA requirements, all data and results for this participant been suppressed .
Secondary
Objective Response Rate
Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1.
Time frame: Up to 18 months
Population: Analyses not performed due to lack of data. Only 1 participant was accrued and available for analysis. This is insufficient for any meaningful statistical analysis and thus no analyses were performed. To comply with HIPAA requirements, all data and results for this participant been suppressed .