Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer

• ClinicalTrials.gov Identifier: NCT00407563
• Recruitment Status: Completed
• First Posted: December 5, 2006
• Results First Posted: April 5, 2012
• Last Update Posted: April 5, 2012
• Sponsor: Accelerated Community Oncology Research Network
• Collaborators: Genentech, Inc.; Celgene Corporation
• Information provided by (Responsible Party): Accelerated Community Oncology Research Network

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Epithelial Ovarian Cancer; Primary Peritoneal Carcinoma	Drug: Bevacizumab; Drug: Abraxane	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study of Bevacizumab With Abraxane in Patients With Recurrent, Platinum-Resistant Primary Epithelial Ovarian or Primary Peritoneal Carcinoma
• Study Start Date: January 2007
• Actual Primary Completion Date: February 2011
• Actual Study Completion Date: February 2011

Arms and Interventions

Intervention Details:

• 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

Outcome Measures

Primary Outcome Measures :

1. 6-month Progression-Free Rate [ Time Frame: 6 months after initiation of study treatment ]
   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.

Secondary Outcome Measures :

1. Best Overall Response [ Time Frame: Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months. ]
   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.
2. Overall Survival [ Time Frame: 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) [ 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. ]
   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.
4. Best Overall Response at Six Months [ Time Frame: Assessed over 6 months of study treatment ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Arkansas

Little Rock Hematology Oncology

Little Rock, Arkansas, United States, 72205

United States, California

Wilshire Oncology Medical Group, Inc.

La Verne, California, United States, 91750

United States, Georgia

Northeast Georgia Cancer Care, LLC

Athens, Georgia, United States, 30607

Southeastern Gynecologic Oncology, LLC

Atlanta, Georgia, United States, 30342

United States, Idaho

North Idaho Cancer Center

Coeur d'Alene, Idaho, United States, 38314

United States, Montana

Hematology-Oncology Centers of the Northern Rockies

Billings, Montana, United States, 59101

United States, Ohio

Mid-Ohio Oncology/Hematology

Columbus, Ohio, United States, 43219

United States, Pennsylvania

Pennsylvania Oncology Hematology Assoc.

Philadelphia, Pennsylvania, United States, 19106

United States, Tennessee

Chattanooga's Program in Women's Oncology

Chattanooga, Tennessee, United States, 37403

The West Clinic

Memphis, Tennessee, United States, 38120

United States, Virginia

Cancer Specialists of Tidewater, Ltd

Chesapeake, Virginia, United States, 23320

Sponsors and Collaborators

Accelerated Community Oncology Research Network

Genentech, Inc.

Celgene Corporation

Investigators

• Principal Investigator: Lee S. Schwartzberg, MD, FACP; The West Clinic

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Accelerated Community Oncology Research Network
• ClinicalTrials.gov Identifier: NCT00407563
• Other Study ID Numbers: ACORN ALSSOPR0501
• First Posted: December 5, 2006
• Results First Posted: April 5, 2012
• Last Update Posted: April 5, 2012
• Last Verified: March 2012

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Ovarian Epithelial; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Paclitaxel; Bevacizumab; Albumin-Bound Paclitaxel; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors