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A Prospective, Phase II Trial of Intravenous Bevacizumab (Avastin) for the Prevention of Recurrent Malignant Ascites

Phase 2
18 Years
Not Enrolling
Malignant Ascites

Thank you

Trial Information

A Prospective, Phase II Trial of Intravenous Bevacizumab (Avastin) for the Prevention of Recurrent Malignant Ascites

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.

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

- 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) 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To determine the repeat paracentesis response rate defined as a doubling of the patient's baseline time to repeat paracentesis.

Outcome Time Frame:

12 weeks after initiation of study treatment

Safety Issue:


Principal Investigator

Martha P Mims, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

July 2009

Completion Date:

February 2011

Related Keywords:

  • Malignant Ascites
  • malignant ascites
  • bevacizumab
  • vascular endothelial growth factor (VEGF)
  • paracentesis
  • Ascites



Baylor College of Medicine Houston, Texas  77030
Ben Taub General Hospital Houston, Texas  77030
Michael E. DeBakey Veterans Affairs Medical Center Houston, Texas  77030