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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00408070 |
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Date of registration:
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05/12/2006 |
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Primary sponsor: |
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Public title:
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Bevacizumab Study With Carboplatin & Paclitaxel in Ovarian, Fallopian Tube or Primary Peritoneal Cancer
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Scientific title:
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Phase 2 Study of Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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5 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00408070 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Carolyn Runowicz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Connecticut Health Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- diagnosis of primary peritoneal carcinoma, fallopian tube epithelial ovarian
carcinoma,
- stage III suboptimal surgery or biopsy,
- stage IV disease
- no prior chemotherapy
Exclusion Criteria:
- unstable heart conditions
- high blood pressure
- vascular disorders
- bleeding problems
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Fallopian Tube Cancer
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Ovarian Cancer
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Peritoneal Cancer
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Stage 3 Cancer
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Stage 4 Cancer
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Intervention(s)
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Drug: Bevacizumab
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Drug: Carboplatin
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Drug: Paclitaxel
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Primary Outcome(s)
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Progression Free Survival Rate at 9 Months
[Time Frame: 9 months]
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Secondary Outcome(s)
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Determine Tolerability to 12 Months (q 3 Weeks) of Bevacizumab Maintenance Therapy
[Time Frame: 12 months]
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Rate of Decline of CA-125
[Time Frame: not assessed; study terminated early]
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Response to Treatment (Clinical/Pathological)
[Time Frame: not assessed; study terminated early]
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To Determine the Degree and Type of Toxicity of This Combined Regimen
[Time Frame: weekly]
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Secondary ID(s)
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AVF 3696s
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IRB 06-337-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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