The purpose of this study is to determine whether the combination of topotecan, cisplatin and bevacizumab is effective in the treatment of recurrent or persistent cervical cancer
Cervical cancer remains a major cause of morbidity and mortality in women. Chemoradiation has led to improvements in survival, but the prognosis for patients with recurrent, metastatic cervical cancer remains poor. There is the need for more effective treatments for the management of recurrent/persistent cervical cancer. Angiogenesis appears to play an important role in cervical cancer development and progression, therefore VEGF inhibition appears to be a rationale therapeutic strategy for cervical cancer. There is increasing evidence that combining an anti-angiogenic agent with either cytotoxic chemotherapy or radiation enhances anti-tumor activity. This study combines the current most active chemotheraputic regimen for cervical cancer (cisplatin + topotecan) with an anti-angiogenic agent.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Washington University School of Medicine
St Louis, Missouri, United States
Duke Cancer Institute
Durham, North Carolina, United States
The Ohio State University College of Medicine
Columbus, Ohio, United States
Anti-tumor Activity as Measured by Surviving Progression-free
Defined as the period from study entry until documentation of disease progression, death, or date of last contact, whichever occurred first.
Time frame: Progression-free survival at 6 months
Overall Survival
Defined as time from study entry until death from any cause or date of last contaqct.
Time frame: Until death (follow-up ranged from 1.7 months to 33.4 months)
Frequency of Response as Measured by RECIST Criteria (Imaging)
RECIST criteria: Complete response is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Progression is defined as ANY of the following - 20% increase in the sum of LD target lesions, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease, progression of existing non-target lesions Stable disease is any condition not meeting the above criteria
Time frame: Tumor response measured prior to every other cycle of therapy (range of follow-up to measure overall response was 1.6-9.5 months)
Correlate Patterns of Gene Expression as Assessed by Microarrays
Time frame: Correlative studies when specimens available
Correlate Hypoxia Inducible Factor 1 (HIF-1) and Hypoxia Induced Gene Expression as Measured by Laboratory Studies
Time frame: When specimens available
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