Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer

This study has been completed.
Sponsor:
Collaborators:
Genentech
Celgene Corporation
Information provided by (Responsible Party):
Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier:
NCT00407563
First received: December 4, 2006
Last updated: March 8, 2012
Last verified: March 2012

December 4, 2006
March 8, 2012
January 2007
February 2011   (final data collection date for primary outcome measure)
6-month Progression-Free Rate [ Time Frame: 6 months after initiation of study treatment ] [ Designated as safety issue: No ]
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.
Evaluate antitumor activity and toxicity profile, demonstrated by the percentage of patients with progression-free response at 6 months after initiation of treatment.
Complete list of historical versions of study NCT00407563 on ClinicalTrials.gov Archive Site
  • Best Overall Response [ Time Frame: Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months. ] [ Designated as safety issue: No ]
    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.
  • Overall Survival [ Time Frame: Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months. ] [ Designated as safety issue: No ]
  • Progression-free Survival (PFS) [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.
  • Best Overall Response at Six Months [ Time Frame: Assessed over 6 months of study treatment ] [ Designated as safety issue: No ]
    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.
  • Overall response rate (ORR [complete response [CR] + partial response [PR]
  • Overall survival
  • Changes from baseline in PCM score
  • Time to progression (TTP), will be evaluated as it relates to the number of cycles prior to progression and duration (months)
  • Incidence and type of treatment-emergent adverse events
  • Changes from baseline in clinical laboratory values, blood pressure, and physical examination findings.
Not Provided
Not Provided
 
Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Epithelial Ovarian Cancer
  • Primary Peritoneal Carcinoma
  • Drug: Bevacizumab
    Bevacizumab will be given via IV infusion at 10mg/kg given on days 1 and 15 of a 28-day cycle.
    Other Name: Avastin
  • Drug: Abraxane
    Abraxane will be given via IV infusion at 100mg/m²over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
    Other Name: albumin-bound paclitaxel
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00407563
ACORN ALSSOPR0501
No
Accelerated Community Oncology Research Network
Accelerated Community Oncology Research Network
  • Genentech
  • Celgene Corporation
Principal Investigator: Lee S. Schwartzberg, MD, FACP The West Clinic
Accelerated Community Oncology Research Network
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP