Topotecan, Cisplatin and Bevacizumab for Recurrent/Persistent Cervical Cancer
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
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Topotecan, Cisplatin and Bevacizumab for Recurrent/Persistent Cervical Cancer|
- Anti-tumor Activity as Measured by Surviving Progression-free [ Time Frame: Progression-free survival at 6 months ] [ Designated as safety issue: No ]Defined as the period from study entry until documentation of disease progression, death, or date of last contact, whichever occurred first.
- Overall Survival [ Time Frame: Until death ] [ Designated as safety issue: No ]Defined as time from study entry until death from any cause or date of last contaqct.
- Frequency of Response as Measured by RECIST Criteria (Imaging) [ Time Frame: Tumor response measured prior to every other cycle of therapy ] [ Designated as safety issue: No ]
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
- Correlate Patterns of Gene Expression as Assessed by Microarrays [ Time Frame: Correlative studies when specimens available ] [ Designated as safety issue: No ]
- Correlate Hypoxia Inducible Factor 1 (HIF-1) and Hypoxia Induced Gene Expression as Measured by Laboratory Studies [ Time Frame: When specimens available ] [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle
Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle
Bevacizumab 15 mg/kg day 1 of a 21 day cycle
Other Name: HycamtinDrug: Cisplatin
Other Names:Drug: Bevacizumab
Other Name: Avastin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548418
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Duke Cancer Institute|
|Durham, North Carolina, United States|
|United States, Ohio|
|The Ohio State University College of Medicine|
|Columbus, Ohio, United States|
|Principal Investigator:||David G Mutch, M.D.||Washington University Early Recognition Center|