Clinical Trials /

Bevacizumab in Ovarian Cancer Patients With Disease at Second-Look Surgery

NCT02884648

Description:

The goal of this clinical research study is to learn if Avastin (bevacizumab) can help to control ovarian, fallopian, or primary peritoneal cancer that has been found during second-look surgery.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Bevacizumab in Ovarian Cancer Patients With Disease at Second-Look Surgery
  • Official Title: A Phase II Investigation of Bevacizumab for the Treatment of Second-Look Positive Epithelial Ovarian Cancer

Clinical Trial IDs

  • ORG STUDY ID: 2015-0520
  • SECONDARY ID: Ovarian SPORE
  • SECONDARY ID: NCI-2016-01970
  • NCT ID: NCT02884648

Conditions

  • Malignant Neoplasms of Female Genital Organs
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer

Interventions

DrugSynonymsArms
BevacizumabAvastin, Anti-VEGF Monoclonal Antibody, rhyMab-VEGFBevacizumab

Purpose

The goal of this clinical research study is to learn if Avastin (bevacizumab) can help to control ovarian, fallopian, or primary peritoneal cancer that has been found during second-look surgery.

Detailed Description

      Study Drug Administration:

      If you are found to be eligible to take part in the study, you will receive bevacizumab by
      vein over about 30 minutes on Day 1 of every 21-day study cycle.

      Study Visits:

      Your first study visit will be about 5-7 weeks after your second-look surgery so that you
      have time to recover. The study doctor will tell you when you will start having study visits.

      During all cycles:

        -  You will have a physical exam.

        -  Blood (about 3 tablespoons) will be drawn for routine testing. If you can become
           pregnant and the doctor thinks it is needed, part of this routine blood sample may be
           used for a pregnancy test.

      During Cycle 3 and then every 3 cycles after that (Cycles 6, 9, 12, and so on), you will have
      an MRI or CT scan.

      Length of Treatment:

      You may continue to receive bevacizumab for as long as the study doctor thinks it is in your
      best interest. You will no longer be able to take the study drug if the disease gets worse,
      if intolerable side effects occur, or if you are unable to follow study directions.

      Your participation on the study will be over after the end-of-treatment visit.

      End-of-Treatment Visit:

      Within about 7 days after your last dose of bevacizumab:

        -  You will have a physical exam.

        -  Blood (about 3 tablespoons) will be drawn for routine testing. If you can become
           pregnant, part of this sample will be used for a pregnancy test.

      This is an investigational study. Bevacizumab is FDA approved and commercially available for
      the treatment of several types of cancer, including ovarian cancer. However, it is considered
      investigational to use bevacizumab as treatment for cancer found during second-look surgery.

      The study doctor will explain how the study drug is designed to work.

      Up to 35 participants will be enrolled in this study. All will take part at MD Anderson.
    

Trial Arms

NameTypeDescriptionInterventions
BevacizumabExperimentalParticipants receive Bevacizumab by vein on Day 1 of every 21-day study cycle, for as long as study doctor thinks it is in participant's best interest.
  • Bevacizumab

Eligibility Criteria

        Inclusion Criteria:

          1. Signed written Informed Consent.

          2. Age>/= 18 years of age or older.

          3. Histologically confirmed Stage III-IV high-grade epithelial non-mucinous ovarian,
             fallopian tube, or primary peritoneal cancers.

          4. Have received standard of care frontline surgical and chemotherapy treatment (at least
             six cycles of platinum and taxane therapy). Patients who received neoadjuvant therapy
             are included.

          5. Have undergone a second-look surgery by an MD Anderson Gynecologic Oncology faculty
             after having achieved a complete clinical response to frontline surgery and adjuvant
             chemotherapy as evidenced by (a) normal physical exam, (b) normal CT or positron
             emission computed tomography (PET)-CT of abdomen and pelvis or other equivalent
             imaging, and (c) normalization of CA125 (<35 U/mL).

          6. Histologically confirmed residual ovarian cancer at time of second-look surgery.
             Patients with cytological evidence of malignant cells in washings obtained as part of
             the second look procedure are eligible even if biopsies are negative.

          7. Be willing to allow use of archival tissue from second-look surgery and primary
             surgery or biopsy for use in this study.

          8. Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group
             (ECOG) Performance Scale at the time of screening.

          9. Have adequate organ function as determined by the following laboratory values: a)
             absolute neutrophil count (ANC) >/= 1,000 /mcL; b) Platelets >/= 100,000/mcL; (c) Hgb
             >/= 8 g/dL; (d) Creatinine Clearance >/= 40 mL/min (measured or calculated per local
             practice); (e) Total Bilirubin </= 1.5 × upper limit of normal (ULN) or </= 3 × ULN in
             the case of suspected/documented Gilbert's Syndrome; and (f) AST (SGOT) and ALT (SGPT)
             </= 2.5 X ULN.

         10. Have adequately recovered from second look surgery to be able to start bevacizumab
             within 7 weeks of this procedure.

         11. Negative serum pregnancy within 72 hours prior to receiving the first dose of study
             medication (unless surgically sterile or postmenopausal for greater than one year).

         12. Female subjects of childbearing potential should be willing to use 2 methods of birth
             control or be surgically sterile, or abstain from heterosexual activity for the course
             of the study through 120 days after the last dose of study medication. Subjects of
             childbearing potential are those who have not been surgically sterilized or have not
             been free from menses for > 1 year.

        Exclusion Criteria:

          1. Uncontrolled hypertension as defined by SBP>150 or DBP>90 on at least two separate
             occasions documented in the medical record. Patients would be eligible if blood
             pressure is controlled with appropriate anti-hypertensive therapy. Rescreening after
             this therapy has been instituted is allowed.

          2. Histology showing mucinous or low-grade epithelial ovarian carcinoma.

          3. Planned use of maintenance or consolidative therapy.

          4. History of known psychiatric or substance abuse disorders that would interfere with
             cooperation with the requirements of the Study.

          5. History of arterial thrombosis. Patients with history of deep vein thrombosis (DVT)
             are eligible as long as they have received or are receiving appropriate
             anticoagulation therapy.

          6. History of gastrointestinal or urinary fistulae, non-healed or chronic wound, or other
             conditions that, in the investigator's view, would contraindicate or significantly
             increase the risks of bevacizumab therapy.

          7. History of known hemoptysis, gastrointestinal or intracerebral hemorrhage.

          8. Patient that is not able to understand or to comply with the study instructions and
             requirements, or has a history of non-compliance to the medical regimen.

          9. Concurrent or planned use of any other anti-cancer systemic chemotherapy, biological
             therapy (including hormonal or immune therapy), radiation therapy, or live cancer
             vaccines.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-Free Survival (PFS) of Participants with Positive Second-Look Findings Treated with Bevacizumab
Time Frame:63 days
Safety Issue:
Description:PFS defined as the interval between the first dose of Bevacizumab and radiographically demonstrated progression by RECIST criteria.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Trial Keywords

  • Malignant neoplasms of female genital organs
  • Ovarian Cancer
  • Fallopian tube cancer
  • Primary peritoneal cancer
  • Bevacizumab
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMab-VEGF

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