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Malignant AscitesPhase 2NCT00908219

A Study of Bevacizumab to Prevent Malignant Ascites

A Phase 2 study testing Bevacizumab in people with Malignant Ascites, run by Baylor College of Medicine at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Ascites
What is being tested?
Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
Jul 2009to Feb 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • Michael E. DeBakey Veterans Affairs Medical Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Bevacizumab
Keywords
malignant ascites, bevacizumab, vascular endothelial growth factor (VEGF), paracentesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Also called Avastin; RO4876646

    Bevacizumab is given as an IV infusion of 15 mg/kg every three weeks for 12 weeks.

Study groups in NCT00908219
Study groupRoleWhat they receive
Bevacizumab IVExperimentalAll 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.
Receives: Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 weeks after initiation of study treatment

Secondary outcomes (3)

  1. 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.

    Measured: Unspecified - depends upon when subject will need repeat paracentesis

  2. To analyze the mean number of paracentesis procedures required in each patient over the course of three months.

    Measured: 12 weeks after the initiation of study treatment

  3. To assess the effect of anti-VEGF therapy on quality of life in patients with malignant ascites.

    Measured: Every three weeks while on-study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Why it stopped: Accrual closed by sponsor due to lack of accrual and study progress

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00908219
Sponsor's protocol ID
H-21728
Other IDs
AVF4534s
Status last verified
Feb 2012
First submitted
21 May 2009
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

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

  • Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. doi: 10.1056/NEJMoa032691.

    PubMed 15175435

  • Smith EM, Jayson GC. The current and future management of malignant ascites. Clin Oncol (R Coll Radiol). 2003 Apr;15(2):59-72. doi: 10.1053/clon.2002.0135.

    PubMed 12708713

  • Xu L, Yoneda J, Herrera C, Wood J, Killion JJ, Fidler IJ. Inhibition of malignant ascites and growth of human ovarian carcinoma by oral administration of a potent inhibitor of the vascular endothelial growth factor receptor tyrosine kinases. Int J Oncol. 2000 Mar;16(3):445-54. doi: 10.3892/ijo.16.3.445.

    PubMed 10675474

  • Yukita A, Asano M, Okamoto T, Mizutani S, Suzuki H. Suppression of ascites formation and re-accumulation associated with human ovarian cancer by an anti-VPF monoclonal antibody in vivo. Anticancer Res. 2000 Jan-Feb;20(1A):155-60.

    PubMed 10769648

  • Zebrowski BK, Liu W, Ramirez K, Akagi Y, Mills GB, Ellis LM. Markedly elevated levels of vascular endothelial growth factor in malignant ascites. Ann Surg Oncol. 1999 Jun;6(4):373-8. doi: 10.1007/s10434-999-0373-0.

    PubMed 10379858

  • Verheul HM, Hoekman K, Jorna AS, Smit EF, Pinedo HM. Targeting vascular endothelial growth factor blockade: ascites and pleural effusion formation. Oncologist. 2000;5 Suppl 1:45-50. doi: 10.1634/theoncologist.5-suppl_1-45.

    PubMed 10804091

  • Luo JC, Toyoda M, Shibuya M. Differential inhibition of fluid accumulation and tumor growth in two mouse ascites tumors by an antivascular endothelial growth factor/permeability factor neutralizing antibody. Cancer Res. 1998 Jun 15;58(12):2594-600.

    PubMed 9635584

  • Zebrowski BK, Yano S, Liu W, Shaheen RM, Hicklin DJ, Putnam JB Jr, Ellis LM. Vascular endothelial growth factor levels and induction of permeability in malignant pleural effusions. Clin Cancer Res. 1999 Nov;5(11):3364-8.

    PubMed 10589746

  • Senger DR, Galli SJ, Dvorak AM, Perruzzi CA, Harvey VS, Dvorak HF. Tumor cells secrete a vascular permeability factor that promotes accumulation of ascites fluid. Science. 1983 Feb 25;219(4587):983-5. doi: 10.1126/science.6823562.

    PubMed 6823562

  • Numnum TM, Rocconi RP, Whitworth J, Barnes MN. The use of bevacizumab to palliate symptomatic ascites in patients with refractory ovarian carcinoma. Gynecol Oncol. 2006 Sep;102(3):425-8. doi: 10.1016/j.ygyno.2006.05.018. Epub 2006 Jun 23.

    PubMed 16797681

  • Pichelmayer O, Gruenberger B, Zielinski C, Raderer M. Bevacizumab is active in malignant effusion. Ann Oncol. 2006 Dec;17(12):1853. doi: 10.1093/annonc/mdl143. Epub 2006 Jun 21. No abstract available.

    PubMed 16790519

  • Ozcan C, Wong SJ, Hari P. Reversible posterior leukoencephalopathy syndrome and bevacizumab. N Engl J Med. 2006 Mar 2;354(9):980-2; discussion 980-2. No abstract available.

    PubMed 16514715

  • Scappaticci FA, Fehrenbacher L, Cartwright T, Hainsworth JD, Heim W, Berlin J, Kabbinavar F, Novotny W, Sarkar S, Hurwitz H. Surgical wound healing complications in metastatic colorectal cancer patients treated with bevacizumab. J Surg Oncol. 2005 Sep 1;91(3):173-80. doi: 10.1002/jso.20301.

    PubMed 16118771

  • Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.

    PubMed 17167137

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab in people with Malignant Ascites, run by Baylor College of Medicine at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00908219, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.

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