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


Phase 2
18 Years
N/A
Not Enrolling
Female
Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-month Progression-Free Rate

Outcome Description:

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.

Outcome Time Frame:

6 months after initiation of study treatment

Safety Issue:

No

Principal Investigator

Lee S. Schwartzberg, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

The West Clinic

Authority:

United States: Institutional Review Board

Study ID:

ACORN ALSSOPR0501

NCT ID:

NCT00407563

Start Date:

January 2007

Completion Date:

February 2011

Related Keywords:

  • Epithelial Ovarian Cancer
  • Primary Peritoneal Carcinoma
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

North Idaho Cancer CenterCoeur d'Alene, Idaho  83814
Wilshire Oncology Medical Group, Inc.Rancho Cucamonga, California  91730
Northeast Georgia Cancer Care, LLCAthens, Georgia  30607
Hematology-Oncology Centers of the Northern RockiesBillings, Montana  59101
The West ClinicMemphis, Tennessee  38120
Chattanooga's Program in Women's OncologyChattanooga, Tennessee  37403
Little Rock Hematology OncologyLittle Rock, Arkansas  72205
Southeastern Gynecologic Oncology, LLCAtlanta, Georgia  30342
Mid-Ohio Oncology/HematologyColumbus, Ohio  43219
Pennsylvania Oncology Hematology Assoc.Philadelphia, Pennsylvania  19106
Cancer Specialists of Tidewater, LtdChesapeake, Virginia  23320