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
5
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