Clinical trial NCT00407563: Bevacizumab With Abraxane in Patients With Recurrent Ovarian/ Peritoneal Cancer
Official title: A Phase 2 Study of Bevacizumab With Abraxane in Patients With Recurrent, Platinum-Resistant Primary Epithelial Ovarian or Primary Peritoneal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epithelial Ovarian Cancer
Primary Peritoneal Carcinoma
Lead sponsor: Accelerated Community Oncology Research Network
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Celgene Corporation
First posted: 2006-12-05
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 6-month Progression-Free Rate
timeFrame: 6 months after initiation of study treatment
Secondary outcomes:
measure: Best Overall Response
timeFrame: Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months.
measure: Overall Survival
timeFrame: Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months.
measure: Progression-free Survival (PFS)
timeFrame: 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.
measure: Best Overall Response at Six Months
timeFrame: Assessed over 6 months of study treatment
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Little Rock Hematology Oncology
state: Arkansas
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group, Inc.
state: California
city: Athens
country: United States
facility: Northeast Georgia Cancer Care, LLC
state: Georgia
city: Atlanta
country: United States
facility: Southeastern Gynecologic Oncology, LLC
state: Georgia
city: Coeur d'Alene
country: United States
facility: North Idaho Cancer Center
state: Idaho
city: Billings
country: United States
facility: Hematology-Oncology Centers of the Northern Rockies
state: Montana
city: Columbus
country: United States
facility: Mid-Ohio Oncology/Hematology
state: Ohio
city: Philadelphia
country: United States
facility: Pennsylvania Oncology Hematology Assoc.
state: Pennsylvania
city: Chattanooga
country: United States
facility: Chattanooga's Program in Women's Oncology
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Chesapeake
country: United States
facility: Cancer Specialists of Tidewater, Ltd
state: Virginia
Study officials:
affiliation: The West Clinic
name: Lee S. Schwartzberg, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.