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

NCT03412630 | Terminated Results FDA Device

• 3 other identifiers: EAE161NCI-2017-01029U10CA180820
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Objective Response Rate

  Up to 18 months

Study Arms (1)

Diagnostic (computed tomography perfusion imaging)

EXPERIMENTAL

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.

Radiation: Computed Tomography Perfusion Imaging

Interventions

Computed Tomography Perfusion Imaging RADIATION

Undergo computed tomography perfusion imaging

Diagnostic (computed tomography perfusion imaging)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• ECOG-ACRIN Cancer Research Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

ECOG-ACRIN Cancer Research Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Cytidine Triphosphate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Results Point of Contact

• Title: Study Statistician
• Organization: ECOG-ACRIN Statistical Office

ecog-acrin@stat.brown.edu

4018639181

Study Officials

• Susanna Lee

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 26, 2018
• Study Start: December 13, 2018
• Primary Completion: March 19, 2019
• Study Completion: July 22, 2020
• Last Updated: November 24, 2023
• Results First Posted: September 27, 2022

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)