Status:
TERMINATED
Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Dana-Farber Cancer Institute
Massachusetts General Hospital
Conditions:
Ovarian Cancer
Primary Peritoneal Serous Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate how the participant's disease (ovarian, primary peritoneal serous, fallopian tube, or papillary serous endometrial cancer) responds to additional treatment wit...
Detailed Description
OBJECTIVES: Primary: To determine the activity of bevacizumab in patients with epithelial ovarian, primary peritoneal serous, papillary serous endometrial or fallopian tube cancer who relapse after ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal serous cancer, papillary serous endometrial cancer, or fallopian tube cancer
- Must have responded and remained clinically stable (as defined by normal clinical examination, normal serum CA125 level and normal CT scan) after first-line platinum-based regimen followed by bevacizumab maintenance therapy
- Must have developed relapsed disease at least 3 months after completion of bevacizumab maintenance therapy as defined by a) development of new, measurable lesions by RECIST criteria, but no lesion with maximum diameter greater than 3 centimeters OR b) newly elevated CA125 level at least 2 x ULN on 2 separate occasions, obtained at least 1 day but not more than 3 months apart
- ECOG Performance Status 0-2
- No prior cytotoxic chemotherapy or biologic therapy for disease recurrence allowed
- Prior hormonal-based therapy for ovarian, primary peritoneal serous or fallopian tube cancer is allowed
- Toxic side effects related to prior chemotherapy or hormonal therapy must have resolved to grade one or less or to baseline before initiation of bevacizumab
- 18 years of age or older
- Life expectancy of 6 months or greater
- Normal organ and marrow function as outlined in the protocol
Exclusion
- Prior cytotoxic chemotherapy or biologic therapy for disease recurrence
- Known CNS disease, except for treated brain metastasis
- Pregnancy or breast feeding
- Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0, or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular device, within 7 days prior to enrollment
- History of abdominal fistula, GI perforation, intra-abdominal abscess, or CT evidence of bowel obstruction or bowel wall thickening
- Symptoms of intestinal obstruction, or requirement of parenteral hydration and/or nutrition
- History of active malignancy during the last 3 years, except non-melanomatous skin cancer or in situ breast or cervical cancer
- Evidence of preexisting uncontrolled hypertension. If patient has hypertension, it must be medically controlled (\< 150/90) prior to starting bevacizumab
- Proteinuria at screening
- Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent
- Therapeutic anticoagulation is not by itself and exclusion criterion. However, for certain high risk patients on therapeutic anticoagulation, eligibility will be determined after discussion with the overall PI
- Any active bleeding
- Serious, non-healing wound, ulcer, or bone fracture
- Prior history of hypertensive crisis or hypertensive encephalopathy
- NYHA Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to Day 1
- History of stroke or transient ischemic attack within 6 months prior to day 1
- Significant vascular disease within 6 months prior to day 1
- History of hemoptysis within 1 month prior to day 1
- Presence of measurable lesion(s) by RECIST criteria with maximum diameter greater than 3 centimeters
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00866723
Start Date
March 1 2009
End Date
June 1 2012
Last Update
May 22 2018
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215