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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:
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 History of Changes |
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 |
Fallopian Tube Cancer Immunologic Factors Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Bevacizumab Genital Diseases, Female Antibodies, Monoclonal Peritoneal Diseases Ovarian Cancer Immunoglobulins Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female |
Endocrine System Diseases Antimitotic Agents Carboplatin Abdominal Neoplasms Angiogenesis Inhibitors Fallopian Tube Neoplasms Carcinoma Antibodies Digestive System Diseases Paclitaxel Tubulin Modulators Gastrointestinal Neoplasms Peritoneal Neoplasms Endocrinopathy Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Bevacizumab Genital Diseases, Female Antibodies, Monoclonal Neoplasms by Site Therapeutic Uses Peritoneal Diseases Growth Inhibitors Angiogenesis Modulating Agents |
Endocrine Gland Neoplasms Neoplasms by Histologic Type Ovarian Neoplasms Digestive System Neoplasms Growth Substances Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Antimitotic Agents Carboplatin Abdominal Neoplasms Angiogenesis Inhibitors Pharmacologic Actions Fallopian Tube Neoplasms Adnexal Diseases |