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| Tracking Information | |||||
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| First Received Date ICMJE | October 11, 2001 | ||||
| Last Updated Date | August 8, 2009 | ||||
| Start Date ICMJE | April 2002 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00025233 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix | ||||
| Official Title ICMJE | 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) | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Cervical Cancer | ||||
| Intervention ICMJE | Biological: bevacizumab | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Monk BJ, Sill MW, Burger RA, Gray HJ, Buekers TE, Roman LD. Phase II Trial of Bevacizumab in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study. J Clin Oncol. 2009 Jan 12; [Epub ahead of print] | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 51 | ||||
| Completion Date | |||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00025233 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068940, GOG-0227C | ||||
| Study Sponsor ICMJE | Gynecologic Oncology Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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