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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Genentech |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00652119 |
Purpose
Primary Objectives:
Secondary Objectives:
Exploratory Objective:
1. To estimate proportion of patients completing entire course of treatment.
| Condition | Intervention |
|
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer |
Drug: Paclitaxel Drug: Carboplatin Drug: Avastin |
| MedlinePlus related topics: | Cancer Ovarian Cancer |
| ChemIDplus related topics: | Carboplatin Paclitaxel Bevacizumab |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Pilot Trial of Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Treatment of Women With Newly Diagnosed, Optimally Cytoreduced Carcinoma of Mullerian Origin |
| Estimated Enrollment: | 46 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Paclitaxel + Carboplatin + Avastin
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Drug: Paclitaxel
Cycle 1 = 60 mg/m^2 IV weekly over 1 hour x 3 weeks; Cycles 2-6 = 60 mg/m^2 IP weekly over 1 hour x 3 weeks of each cycle.
Drug: Carboplatin
Cycle 1 = AUC 6 IV over 1 hour on day 1; Cycles 2-6 = AUC 6 IP over 1 hour on day 1 of each cycle.
Drug: Avastin
Cycle 2 = 15 mg/kg IV over 90 minutes on day 8; Cycles 3-6 = 15 mg/kg IV on day 1 of each cycle.
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Judith Wolf, MD | 713-792-7310 |
| United States, Maryland | |||||
| Johns Hopkins Hospital | Recruiting | ||||
| Baltimore, Maryland, United States, 21287 | |||||
| United States, Massachusetts | |||||
| Massachusetts General Hospital | Recruiting | ||||
| Boston, Massachusetts, United States, 02114 | |||||
| United States, Pennsylvania | |||||
| Fox Chase Cancer Center | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19111 | |||||
| United States, Texas | |||||
| U.T.M.D. Anderson Cancer Center | Recruiting | ||||
| Houston, Texas, United States, 77030 | |||||
| Principal Investigator: Judith Wolf, MD | |||||
| United States, Washington | |||||
| University of Washington | Recruiting | ||||
| Seattle, Washington, United States, 98195 | |||||
| M.D. Anderson Cancer Center |
| Genentech |
| Principal Investigator: | Judith Wolf, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Judith Wolf, MD/Associate Professor ) |
| Study ID Numbers: | 2007-0223 |
| First Received: | March 31, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00652119 |
| Health Authority: | United States: Institutional Review Board |
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