Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer

Brief Title

Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer

Official Title

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

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 with Avastin (bevacizumab). Participants 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.

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
      achieving an initial complete response to first-line therapy that included at least 6 month
      bevacizumab maintenance as defined by: 1) clinical response rate OR 2) clinical benefit
      response

      Secondary:

        -  To assess duration of progression free survival (PFS)

        -  To assess the safety

        -  To correlate response with the Avastin-free interval

      STATISTICAL DESIGN:

      This study used a two-stage design to evaluate efficacy of bevacizumab based on a patient
      achieving either clinical response or clinical benefit response. The null and alternative
      response rates were 10% and 30%. If two or more patients enrolled in the stage one cohort
      (n=10 patients) achieved response than accrual would proceed to stage two (n=19 patients). If
      response was achieved by at least 6 patients in the final set of 29 evaluable patients then
      bevacizumab would be deemed worthy for further study. This design had 80% power given
      one-sided 0.05 significance level.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Clinical Response Rate

Condition

Ovarian Cancer

Intervention

bevacizumab

Study Arms / Comparison Groups

 bevacizumab

Description:  Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

March 2009

Completion Date

June 2012

Primary Completion Date

December 2011

Eligibility 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Panagiotis Konstantinopoulos, MD, PhD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00866723

Organization ID

08-323

Responsible Party

Principal Investigator

Study Sponsor

Beth Israel Deaconess Medical Center

Collaborators

 Dana-Farber Cancer Institute

Study Sponsor

Panagiotis Konstantinopoulos, MD, PhD, Principal Investigator, Beth Israel Deaconess Medical Center

Verification Date

May 2018