Perfusion CT to Predict Progression-free Survival and Response Rate in Bevacizumab and Paclitaxel Treantment of Platinum-Resistant Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Carcinoma

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0004506
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 184

Inclusion Criteria

1 Registration to Step 0
1.1 Patient must be female = 18 years of age.
1.2 Pateint must have epithelial ovarian, fallopian tube, or primary peritoneal cancer. This includes high-grade serous ovarian cancer, endometroid, clear cell, mixed epithelial, undifferentiated carcinoma, transitional cell carcinoma histologies.
1.3 Patient must have suspected platinum-resistant disease (disease progression = 6 months of platinum therapy).
1.4 Patient must be expected to undergo therapy with bevacizumab in combination with paclitaxel at recommended standard of care doses if suspected recurrence is confirmed with imaging. Patient must be able and willing to provide written informed consent.
1.5 Patient must have a life expectancy of = 3 months.3
1.6 Patient must have adequate bone marrow, coagulation, renal, and hepatic function; eGFR(glomerular filtration rate) calculation = 60 mL/min/1.73 m2 (within 28 days of screening CT submission)
1.7 Patient must demonstrate an ECOG(Eastern Cooperative Onocology Group) performance status of 0-2.

2 Registration to Step 1
Note: The ACR(American College of Radiology) Imaging Core Lab will evaluate the potential target lesion once all required images are received and inform the site within five business days if patient is eligible and may be registered to Step 1 and scheduled for perfusion CT imaging. The local site will receive notification of eligibility via RAVE.
2.1 Patient must be evaluable using RECIST 1.1 criteria.
2.2 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 HU on the unenhanced CT scan) on a contrast-enhanced conventional CT.
2.3 Conventional chest abdomen and pelvis CT images demonstrating recurrent tumor must be submitted within 21 days from acquisition to the ACR(American College of Radiology) Core Lab
2.4 Eligibility of a perfusion CT target lesion must be confirmed by the ACR(American College of Radiology) Core Lab prior to study enrollment and the T0 perfusion CT scan.

Exclusion Criteria

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1.1 Patients with carcinosarcoma, non-epithelial, low grade tumors, or tumors with low malignant potential are excluded.
1.2 Patient must not have undergone therapy with any VEGF monoclonal antibodies in the last twelve weeks. Patient must not have received any small molecule anti-VEGF drug within the previous 4 weeks.
1.3 Patient must not have undergone major surgery or radiotherapy to the pelvis or abdomen within previous 4 weeks.
1.4 Patients must not have known contraindications to bevacizumab, including but not limited to abdominal fistula, 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.
1.5 Patient must not have untreated or symptomatic CNS(Central nervous system) metastasis.
1.6 Patient must not have another active (within past 3 years) or concurrent malignancy. Resected basal cell skin cancer is allowed within past 3 years.
1.7 Patient must not have contraindication to iodinated contrast.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free Survival