A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer
Tracking Information
Start Date ICMJE | June 2009 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: July 10, 2009) | Progression-free survival [ Time Frame: assessed after cycles 3,6 and 9 of triple treatment and every 18 weeks on maintenance monotherapy ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00937560 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: July 10, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer |
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Official Title ICMJE | |
Brief Summary | This single arm study will evaluate the efficacy and safety of first line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus Avastin in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer. patients will receive 6 to 9 x 3-week cycles of treatment with Avastin (7.5mg/kg iv on day 1 of each cycle), paclitaxel (80mg/m2 iv on days 1, 8 and 15 of each cycle) and carboplatin (iv to an AUC of 6 on day 1 of each cycle).Following combination chemotherapy, Avastin may continue to be given as monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. |
Detailed Description | |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Condition ICMJE | Ovarian Cancer |
Intervention ICMJE |
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Study Arms / Comparison Groups | 1: Experimental Interventions:
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Recruitment Information
Estimated Enrollment ICMJE | 180 | ||||
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Estimated Completion Date | May 2012 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Brazil, France, Italy, Netherlands, Norway, Russian Federation, Spain, Sweden, Switzerland, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00937560 | ||||
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Responsible Party | Disclosures Group, Hoffmann-La Roche | ||||
Study ID Numbers ICMJE | MO22225, 2008-008336-85 | ||||
Study Sponsor ICMJE | Hoffmann-La Roche | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Hoffmann-La Roche |
Source: http://clinicaltrials.gov/