Spots Global Cancer Trial Database for ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
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Trial Identification
Brief Title: ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
Official Title: A Phase II Evaluation of ABI-007 in the Treatment of Persistent or Recurrent Squamous or Nonsquamous Cell Carcinoma of the Cervix
Study ID: NCT00309959
Study Description
Brief Summary: This phase II trial is studying how well ABI-007 works in treating patients with persistent or recurrent cervical cancer. Drugs used in chemotherapy, such as ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed Description: OBJECTIVES: I. 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 treatment protocols. II. Determine the nature and degree of toxicity of ABI-007 in this cohort of patients. III. 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.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States
Rush University Medical Center, Chicago, Illinois, United States
Carle Clinic-Urbana Main, Urbana, Illinois, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Iowa Oncology Research Association CCOP, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County, Mount Holly, New Jersey, United States
Virtua West Jersey Hospital Voorhees, Voorhees, New Jersey, United States
Women's Cancer Care Associates LLC, Albany, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Lake University Ireland Cancer Center, Mentor, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Tulsa Cancer Institute, Tulsa, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Lyndon Baines Johnson General Hospital, Houston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
Carilion Clinic Gynecological Oncology, Roanoke, Virginia, United States
Saint Vincent Hospital, Green Bay, Wisconsin, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Contact Details
Name: David Alberts
Affiliation: Gynecologic Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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