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

NCT00866723 | Terminated Phase 2 Results DMC

• 1 other identifier: 08-323
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

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.

Conditions

Ovarian Cancer; Primary Peritoneal Serous Cancer; Fallopian Tube Cancer

Keywords

Avastin; bevacizumab

Outcome Measures

Primary Outcomes (2)

• Clinical Response Rate

  For measurable disease (MD) patients, clinical response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. For non-MD patients, clinical response based on modified Gynecologic Cancer Intergroup (GCIG) criteria was defined as at least a 50% decrease in CA-125 levels.

  Disease was evaluated at baseline and every 3 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Patients underwent radiologic assessment (CT or MRI scans) and CA-125 levels were measured.

• Clinical Benefit Response Rate

  Clinical benefit response was defined as absence of disease progression at 18 weeks (ie after 6 cycles). Disease progression (PD) could occur per RECIST 1.0 or based on CA-125 levels. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Disease progression based on CA-125 level was doubling of the CA-125 level from baseline. For patients with normal baseline CA-125 (who by definition had MD) the criterion for progression based on CA-125 doubling was doubling of CA-125 from the upper limit of normal (i.e. more than 70).

  Disease was evaluated at baseline and every 3 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Patients underwent radiologic assessment (CT or MRI scans) and CA-125 levels were measured.

Study Arms (1)

bevacizumab

EXPERIMENTAL

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

Drug: bevacizumab

Interventions

bevacizumab DRUG

Also known as: Avastin

bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• Life expectancy of 6 months or greater
• Normal organ and marrow function as outlined in the protocol

You may not qualify if:

• 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
• Any active bleeding
• Serious, non-healing wound, ulcer, or bone fracture
• Prior history of hypertensive crisis or hypertensive encephalopathy

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Dana-Farber Cancer Institute: collaborator
• Massachusetts General Hospital: collaborator
• Genentech, Inc.: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Konstantinopoulos PA, Berlin ST, Campos SM, Matulonis UA, Cannistra SA. Bevacizumab rechallenge after first line maintenance bevacizumab. Gynecol Oncol. 2012 May;125(2):510-1. doi: 10.1016/j.ygyno.2012.02.013. Epub 2012 Feb 21. No abstract available.

  PMID: 22366591 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Panagiotis Konstantinopoulos
• Organization: Dana-Farber Cancer Institute

panagiotisa_konstantinopoulos@dfci.harvard.edu

(617) 632-5269

Study Officials

• Panagiotis Konstantinopoulos, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: May 22, 2018
• Results First Posted: November 25, 2014

Record last verified: 2018-05

Locations

US (3)