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Phase II Study of Single-Agent Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer Who Have Recurred After Prior Therapy With Maintenance Avastin

Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Primary Peritoneal Serous Cancer, Fallopian Tube Cancer

Thank you

Trial Information

Phase II Study of Single-Agent Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer Who Have Recurred After Prior Therapy With Maintenance Avastin

- Participants will receive Avastin as an intravenous infusion through a vein once every
21 days. This 21 day period is referred to as a "cycle".

- The following tests and procedures will be performed every cycle: Medical history;
blood tests; evaluation of any side effects; urine test.

- An assessment of the tumor by Computerized Tomography (CT) or equivalent scan will be
performed every three cycles.

- An Electrocardiogram (ECG) will be performed before beginning treatment.

Inclusion Criteria:

- Histologically or cytologically confirmed epithelial ovarian cancer, primary
peritoneal serous cancer, papillary serous endometrial cancer, or fallopian tube

- 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 Criteria:

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the activity of bevacizumab as defined by 1) clinical response rate OR 2) clinical benefit response refined as percent progression-free at 18 weeks in this patient population

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Panagiotis Konstantinopoulos, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Serous Cancer
  • Fallopian Tube Cancer
  • Avastin
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617