A Phase II Investigation of Bevacizumab for the Treatment of Second-look Positive Epithelial Ovarian Cancer
Amir A. Jazaeri
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.
Disease Group: Malignant neoplasms of female genital organs
Treatment Agent: Bevacizumab
Treatment Location: Only at MD Anderson
Primary Objective To estimate progression-free survival (PFS) of patients with positive second-look findings treated with bevacizumab. PFS will be defined as the interval between the first dose of bevacizumab and radiographically demonstrated progression by RECIST criteria. Secondary Objectives To describe molecular features of chemoresistant ovarian cancers discovered at second-look assessment. To compare expression pattern of Aplasia Ras Homolog Member I (ARHI) and other autophagy markers in the primary untreated and second look tumor specimens.
IRB Review and Approval Date: 11/15/2016
Recruitment Status: Open
Projected Accrual: N/A
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 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 ECOG Performance Scale at the time of screening.
9) Have adequate organ function as determined by the following laboratory values: a) 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 × 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.
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 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.
Information and next steps
Malignant neoplasms of female genital organs
Amir A. Jazaeri
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