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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Genentech |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00652119 |
Primary study goals:
Secondary study goals:
Exploratory goal:
-To estimate proportion of patients completing entire course of treatment
Condition | Intervention |
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Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer |
Drug: Paclitaxel Drug: Carboplatin Drug: Avastin |
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 |
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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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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Judith Wolf, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Judith Wolf, MD/Associate Professor ) |
Study ID Numbers: | 2007-0223 |
Study First Received: | March 31, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00652119 |
Health Authority: | United States: Institutional Review Board |
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Carcinoma of Mullerian Origin Paclitaxel Taxol |
Carboplatin Paraplatin® Avastin Bevacizumab Anti-VEGF monoclonal antibody rhuMAb-VEGF |
Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Bevacizumab Antibodies, Monoclonal Genital Diseases, Female Peritoneal Diseases Immunoglobulins Endocrine Gland Neoplasms Ovarian cancer Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases |
Carboplatin Abdominal Neoplasms Fallopian Tube Neoplasms Carcinoma Fallopian Tube Diseases Antibodies Digestive System Diseases Paclitaxel Gastrointestinal Neoplasms Peritoneal Neoplasms Fallopian tube cancer Endocrinopathy Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Angiogenesis Inhibitors |
Pharmacologic Actions Adnexal Diseases Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |