A Phase II Evaluation of ABI-007 (IND #55,974) in the Treatment of Persistent or Recurrent Squamous or Nonsquamous Cell Carcinoma of the Cervix
- Estimate the antitumor activity of ABI-007 in patients with persistent or recurrent
squamous or nonsquamous cell carcinoma of the cervix who have failed on higher-priority
- Determine the nature and degree of toxicity of ABI-007 in this cohort of patients.
- To determine the expression of the SPARC (secreted protein, acidic and rich in
cysteine) protein in the tumor tissue and plasma (exploratory study) of patients
treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive ABI-007 IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28
days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and periodically during study for SPARC protein
expression analysis by ELISA. Archived tumor tissue samples are also analyzed.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
David S. Alberts, MD
University of Arizona
United States: Food and Drug Administration
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|MetroHealth Cancer Care Center at MetroHealth Medical Center||Cleveland, Ohio 44109|
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center||Madison, Wisconsin 53792-6164|
|Marshfield Clinic - Marshfield Center||Marshfield, Wisconsin 54449|
|Rush University Medical Center||Chicago, Illinois 60612-3824|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|John Stoddard Cancer Center at Iowa Methodist Medical Center||Des Moines, Iowa 50309|
|Blumenthal Cancer Center at Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|Hulston Cancer Center at Cox Medical Center South||Springfield, Missouri 65807|
|St. John's Regional Health Center||Springfield, Missouri 65804|
|SUNY Downstate Medical Center||Brooklyn, New York 11203|
|Lake/University Ireland Cancer Center||Mentor, Ohio 44060|
|Carilion Gynecologic Oncology Associates||Roanoke, Virginia 24014|
|St. Vincent Hospital Regional Cancer Center||Green Bay, Wisconsin 54307-3508|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Virginia Commonwealth University Massey Cancer Center||Richmond, Virginia 23298-0037|
|Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton||Marlton, New Jersey 08053|
|Cancer Care Associates - Saint Francis Campus||Tulsa, Oklahoma 74136-1929|
|Rosenfeld Cancer Center at Abington Memorial Hospital||Abington, Pennsylvania 19001|
|John Stoddard Cancer Center at Iowa Lutheran Hospital||Des Moines, Iowa 50316-2301|
|Medical Oncology and Hematology Associates at John Stoddard Cancer Center||Des Moines, Iowa 50309|
|Medical Oncology and Hematology Associates at Mercy Cancer Center||Des Moines, Iowa 50314|
|Mercy Cancer Center at Mercy Medical Center - Des Moines||Des Moines, Iowa 50314|
|Cancer Institute of New Jersey at Cooper - Voorhees||Voorhees, New Jersey 08043|
|Gynecologic Oncology||Hinsdale, Illinois 60521|
|University of Colorado Cancer Center at UC Health Sciences Center||Aurora, Colorado 80045|
|Lyndon B. Johnson General Hospital||Houston, Texas 77026-1967|
|Arizona Cancer Center at University Medical Center North||Tucson, Arizona 85719|