A Study of Bevacizumab to Prevent Malignant Ascites

This study has been withdrawn prior to enrollment.
(Accrual closed by sponsor due to lack of accrual and study progress)
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Martha Mims, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00908219
First received: May 21, 2009
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to determine the effectiveness of using Bevacizumab in the prevention of recurrent malignant ascites.

Ascites is a debilitating and unpleasant complication of several types of cancer. Animal and laboratory studies have shown that tumor cell production and/or increases in the amount of Vascular Endothelial Growth Factor (VEGF) is a major cause of the formation of malignant ascites. Therefore, giving patients with malignant ascites a drug that targets and neutralizes VEGF should prevent the recurrence of malignant ascites following paracentesis (a procedure to remove fluid from the abdominal cavity).


Condition Intervention Phase
Malignant Ascites
Drug: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective, Phase II Trial of Intravenous Bevacizumab (Avastin) for the Prevention of Recurrent Malignant Ascites

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • To determine the repeat paracentesis response rate defined as a doubling of the patient's baseline time to repeat paracentesis. [ Time Frame: 12 weeks after initiation of study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the time to the need for the first repeat abdominal paracentesis after the start of Bevacizumab therapy as compared with historical control data. [ Time Frame: Unspecified - depends upon when subject will need repeat paracentesis ] [ Designated as safety issue: No ]
  • To analyze the mean number of paracentesis procedures required in each patient over the course of three months. [ Time Frame: 12 weeks after the initiation of study treatment ] [ Designated as safety issue: No ]
  • To assess the effect of anti-VEGF therapy on quality of life in patients with malignant ascites. [ Time Frame: Every three weeks while on-study ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab IV
All subjects will be treated with an intravenous infusion of the experimental drug (Bevacizumab 15 mg/kg) every 3 weeks for a total of twelve (12) weeks on study.
Drug: Bevacizumab
Bevacizumab is given as an IV infusion of 15 mg/kg every three weeks for 12 weeks.
Other Name: Avastin; RO4876646

Detailed Description:

All subjects will be treated with an intravenous infusion of the experimental drug (Bevacizumab 15 mg/kg) every 3 weeks for a total of twelve (12) weeks on study. The primary endpoint will be time to the need for repeat abdominal paracentesis after the start of therapy. Secondary endpoints will include an analysis of the mean number of paracenteses required in each subject over the course of 3 months, determination of the repeat paracentesis response rate (proportion of subjects who have a doubling in baseline time to repeat paracentesis) and an assessment of the effect of treatment on quality of life using a subject questionnaire.

  Eligibility

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

Inclusion Criteria:

  • Persistent or symptomatic ascites with positive cytology secondary to any histologically confirmed tumor type not amenable to cytoreductive surgery or additional chemotherapy
  • Patients may enroll in this study irrespective of previous therapy including diuretics, surgery, chemotherapy, immunotherapy and radiation therapy
  • Must have received a minimum of two paracentesis procedures and a trial of diuretic therapy within 60 days of study entry
  • Age Restrictions: 18 years and older
  • Life Expectancy: 12 weeks or more
  • ECOG Performance Status: 0 -3
  • Able and willing to provide informed consent and comply with study and/or follow-up procedures
  • Normal organ and marrow function as defined by: Leukocytes >/= 3,000/mcL; Absolute neutrophil count >/= 1,500/mcL; Platelets >/= 100,000/mcL; Total bilirubin within normal institutional limits; AST (SGOT)/ALT(SGPT) </= 2.5 X institutional upper limit of normal (ULN); Creatinine within normal institutional limits OR Creatinine clearance >/+ 60 mL/min for patients with creatinine levels above the institutional normal; Serum Potassium within normal institutional limits; Serum Sodium within normal institutional limits

Exclusion Criteria:

  • Patients having received Bevacizumab as part of the treatment of their malignancy within 60 days prior to study entry
  • Current, recent (within 30 days of the first infusion of this study) or planned administration of chemotherapy (including all routes of administration), immunotherapy, biologic therapy, radiation therapy or any other anti-VEGF therapy (e.g., tyrosine kinase inhibitors)
  • Current, recent (within 30 days of the first infusion of this study), or planned participation in any other experimental drug study
  • Pregnant women; A serum pregnancy test will be given to females of childbearing potential prior to study enrollment and the participant must agree to use adequate contraception (barrier or hormonal methods) prior to study entry and for the duration of study participation.
  • Un-controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg
  • History of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months prior to study entry
  • Known CNS disease, except for treated brain metastasis.
  • Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study entry
  • History of hemoptysis (>/= 1/2 teaspoon of bright red blood per episode) within 1 month prior to study entry
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study entry 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 access device or paracentesis/thoracentesis, within 7 days prior to study entry
  • History of abdominal fistula or gastrointestinal perforation within 6 months prior to study entry
  • Any bowel obstruction that has not fully recovered despite medical or surgical intervention prior to study entry
  • Evidence of bowel wall thickening outside the site of the known primary malignancy on baseline radiographs
  • Serious, non-healing wound, active ulcer, or untreated bone fracture
  • Proteinuria as demonstrated by a Urine Protein/Creatinine ration >/= 1.0 at screening
  • Known hypersensitivity to any component of bevacizumab
  • Intrathoracic lung carcinoma of squamous cell histology.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908219

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Ben Taub General Hospital
Houston, Texas, United States, 77030
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Genentech
Investigators
Principal Investigator: Martha P Mims, MD, PhD Baylor College of Medicine
  More Information

Publications:
Braunwald, et al. Harrison's Principles of Internal Medicine, 15th Ed. (McGraw-Hill 2001) 517

Responsible Party: Martha Mims, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00908219     History of Changes
Other Study ID Numbers: H-21728, AVF4534s
Study First Received: May 21, 2009
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
malignant ascites
bevacizumab
vascular endothelial growth factor (VEGF)
paracentesis

Additional relevant MeSH terms:
Ascites
Pathologic Processes
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 August 21, 2014