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

Stopped early · Not applicable

Conditions studied: Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma

In brief

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.

Key facts

Study ID

NCT03412630

Run by

ECOG-ACRIN Cancer Research Group

People needed

1

Starts

2018-12-13

Expected to finish

2020-07-22

Last updated by the study team

2023-11-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• ECOG-ACRIN Cancer Research Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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