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Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer
This study has been suspended.
( Recruitment has temporarily been suspended while evaluation of resources is conducted. )

First Received on March 19, 2009.   Last Updated on November 17, 2010   History of Changes
Sponsor: Beth Israel Deaconess Medical Center
Collaborators: Dana-Farber Cancer Institute
Massachusetts General Hospital
Genentech
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00866723
  Purpose

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 with Avastin (bevacizumab). Participant's have already received Avastin as part of maintenance therapy for their cancer. Maintenance therapy is a medical therapy that is given to people to prevent a relapse. However, cancer may return after maintenance therapy. This research study hopes to determine whether additional treatment with Avastin will be effective in treating the participant's cancer.


Condition Intervention Phase
Ovarian Cancer
Primary Peritoneal Serous Cancer
Fallopian Tube Cancer
Drug: bevacizumab (Avastin)
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess duration of progression free survival in this patient population [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To assess the safety of single-agent bevacizumab in this patient population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To correlate response with the bevacizumab-free interval [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: March 2009
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: bevacizumab (Avastin)
    Given intravenously every 21 days
    Other Names:
    • Avastin
    • Bevacizumab
Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866723

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Massachusetts General Hospital
Genentech
Investigators
Principal Investigator: Panagiotis Konstantinopoulos, MD, PhD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Panagiotis Konstantinopoulos, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00866723     History of Changes
Other Study ID Numbers: 08-323
Study First Received: March 19, 2009
Last Updated: November 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Avastin

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012