AzTrials
AzTrials

Epithelial Ovarian CancerPhase 2NCT00407563

Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer

A Phase 2 study testing Bevacizumab and Abraxane in people with Epithelial Ovarian Cancer and Primary Peritoneal Carcinoma, run by Accelerated Community Oncology Research Network at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the effectiveness and tolerability of the combination of bevacizumab and Abraxane in the treatment of women with epithelial ovarian cancer or peritoneal cancer. The study will also evaluate how the patient's quality of life is during their treatment. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bevacizumab and Abraxane
Type of treatment
Injection or infusion
How many people
48 participants
Where
11 sitesUnited States
Study dates
Jan 2007to Feb 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Measurable disease by CT or MRI.
  • At least 1 "target lesion" to be used to assess response as defined by GOG RECIST criteria.
  • ECOG performance status of 0 or 1.
  • Patient provides voluntary written informed consent.
  • At least 18 years of age.
  • Negative serum pregnancy test.
Show all 11Show fewer
  • Recovered from any recent surgery for at least 30 days and is free of active infection.
  • Received the following prior therapy at time of enrollment:
  • Must have had 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin or organoplatinum. Initial therapy may have included high-dose therapy, consolidation, or extended therapy. Patient should be defined as recurrent or progression of disease within 6 months of last platinum chemotherapy.
  • May have had 1 additional cytotoxic or non-cytotoxic chemotherapy regimen.
  • Must have adequate hematologic and hepatic function.

Who cannot join

  • Previously received bevacizumab.
  • History of other invasive malignancy with the exception of nonmelanoma skin cancer.
  • ECOG performance status of 2, 3, or 4.
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study. Patient must be bevacizumab naïve.
  • Blood pressure of >150/100 mm Hg on antihypertensive medications.
  • Prior history of hypertensive crisis or hypertensive encephalopathy.
Show all 26Show fewer
  • Diagnosed with unstable angina per NYHA or Grade 2 or greater congestive heart failure.
  • History of myocardial infarction within 6 months of enrollment.
  • History of stroke or transient ischemic attack within 6 months prior to study enrollment.
  • Clinically significant vascular disease (e.g., aortic aneurysm, aortic dissection)or symptomatic peripheral vascular disease.
  • Bleeding diathesis or coagulopathy.
  • Presence of CNS or brain metastases.
  • Pre-existing peripheral neuropathy of Grade ≥ 2.
  • A major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study.
  • A partial or complete small or large bowel obstruction demonstrated radiologically within 3 months prior to study enrollment.
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment.
  • Positive pregnancy test or is lactating.
  • History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Serious intercurrent medical or psychiatric illness, including serious active infection.
  • Inability to comply with study and/or follow-up procedures.
  • Life expectancy of less than 12 weeks.
  • Proteinuria at screening as demonstrated by either:
  • Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening OR
  • Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
  • Known hypersensitivity to any component of bevacizumab.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Northeast Georgia Cancer Care, LLC

    Athens, Georgia, 30607

  • Southeastern Gynecologic Oncology, LLC

    Atlanta, Georgia, 30342

  • Hematology-Oncology Centers of the Northern Rockies

    Billings, Montana, 59101

  • Chattanooga's Program in Women's Oncology

    Chattanooga, Tennessee, 37403

  • Cancer Specialists of Tidewater, Ltd

    Chesapeake, Virginia, 23320

  • North Idaho Cancer Center

    Coeur d'Alene, Idaho, 38314

  • Mid-Ohio Oncology/Hematology

    Columbus, Ohio, 43219

  • Wilshire Oncology Medical Group, Inc.

    La Verne, California, 91750

  • Little Rock Hematology Oncology

    Little Rock, Arkansas, 72205

  • The West Clinic

    Memphis, Tennessee, 38120

  • Pennsylvania Oncology Hematology Assoc.

    Philadelphia, Pennsylvania, 19106

Other trials in United States

About this study

Official title: A Phase 2 Study of Bevacizumab With Abraxane in Patients With Recurrent, Platinum-Resistant Primary Epithelial Ovarian or Primary Peritoneal Carcinoma

The purpose of this study is to evaluate the effectiveness and tolerability of the combination of bevacizumab and Abraxane in the treatment of women with epithelial ovarian cancer or peritoneal cancer. The study will also evaluate how the patient's quality of life is during their treatment.

Being tested
Bevacizumab, Abraxane
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

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

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab will be given via IV infusion at 10mg/kg given on days 1 and 15 of a 28-day cycle.

  • AbraxaneDrug

    Also called albumin-bound paclitaxel

    Abraxane will be given via IV infusion at 100mg/m²over 30 minutes on days 1, 8, and 15 of a 28-day cycle.

What is being measured

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

  1. 6-month Progression-Free Rate

    Progression-free rate is defined as the percentage of participants with no progression event at 6 months after starting study treatment. An event for this endpoint was defined as a progression-free survival event occurring earlier than six months, or discontinuation of treatment earlier than six months for any other reason. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.

    Measured: 6 months after initiation of study treatment

Secondary outcomes (4)

  1. Best Overall Response

    Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.

    Measured: Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months.

  2. Overall Survival

    Measured: Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months.

  3. Progression-free Survival (PFS)

    Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.

    Measured: PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first, assessed up to 30 months.

  4. Best Overall Response at Six Months

    The outcome measure assessed the percentage of participants who had achieved either a Partial or Complete Response over 6 months of treatment. Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.

    Measured: Assessed over 6 months of study treatment

Timeline

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

  1. First posted5 Dec 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

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
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00407563
Sponsor's protocol ID
ACORN ALSSOPR0501
Status last verified
Mar 2012
First submitted
4 Dec 2006
Last updated
5 Apr 2012
Data monitoring committee
No

Publications

  • Tillmanns TD, Lowe MP, Walker MS, Stepanski EJ, Schwartzberg LS. Phase II clinical trial of bevacizumab with albumin-bound paclitaxel in patients with recurrent, platinum-resistant primary epithelial ovarian or primary peritoneal carcinoma. Gynecol Oncol. 2013 Feb;128(2):221-8. doi: 10.1016/j.ygyno.2012.08.039. Epub 2012 Sep 5.

    PubMed 22960352

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab and Abraxane in people with Epithelial Ovarian Cancer and Primary Peritoneal Carcinoma, run by Accelerated Community Oncology Research Network at 11 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 11 inclusion and 26 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: finished, as of the sponsor's last update on 5 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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?

Yes. Results are posted in the registry (first posted 5 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

6-month Progression-Free Rate (time frame: 6 months 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 NCT00407563, which also lists 1 linked publication.

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 5 Apr 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in