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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00025233 |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.
PURPOSE: This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent cancer of the cervix.
Condition | Intervention | Phase |
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Cervical Cancer |
Biological: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Bevacizumab (rhuMAB VEGF) (NSC #704865 IND #7921) In the Treatment of Persistent and Recurrent Squamous Cell Carcinoma of the Cervix (Group A) |
Estimated Enrollment: | 51 |
Study Start Date: | April 2002 |
Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-38 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients must have received at least 1, but no more than 2, prior cytotoxic chemotherapy regimens for advanced, metastatic, or recurrent SCC of the cervix
At least 1 unidimensionally measurable lesion*
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
No proteinuria
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Bradley J. Monk, MD | Chao Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000068940, GOG-0227C |
Study First Received: | October 11, 2001 |
Last Updated: | August 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00025233 History of Changes |
Health Authority: | United States: Federal Government |
recurrent cervical cancer cervical squamous cell carcinoma |
Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Bevacizumab Squamous Cell Carcinoma Angiogenesis Inhibitors Recurrence Carcinoma |
Uterine Cervical Neoplasms Genital Diseases, Female Uterine Cervical Diseases Epidermoid Carcinoma Uterine Neoplasms Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Physiological Effects of Drugs Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Bevacizumab Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Genital Diseases, Female |
Uterine Cervical Neoplasms Neoplasms Uterine Cervical Diseases Neoplasms by Site Therapeutic Uses Uterine Neoplasms Growth Inhibitors Angiogenesis Modulating Agents Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |