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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00583622 |
Primary Endpoint To derive estimates of the therapeutic impact produced by the new treatment, by analyzing the event-free survival (EFS).
Secondary Endpoints:
To Describe the side effect profile of Bevacizumab/Gemcitabine/Docetaxel/Melphalan/Carboplatin (Bev/DMC) and
Bevacizumab/Topotecan/Melphalan/Cyclophosphamide (Bev/TMC):
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: Bevacizumab Drug: Carboplatin Drug: Docetaxel Drug: Gemcitabine Drug: Melphalan Procedure: Stem Cell Transplant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Bevacizumab Combined With High-Dose Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Patients With Advanced Epithelial Ovarian Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Bevacizumab + High-Dose Chemotherapy: Experimental
Bevacizumab + Carboplatin + Docetaxel + Gemcitabine + Melphalan
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Drug: Bevacizumab
5 mg/kg By Vein Daily Over 90 Minutes x 2 Days
Drug: Carboplatin
333 mg/m^2 By Vein Over 2 Hours x 3 Days
Drug: Docetaxel
300 mg/m^2 By Vein Over 2 Hours x 1 Day
Drug: Gemcitabine
2,100 mg/m^2 By Vein Over 4 Hours x 4 Days
Drug: Melphalan
50 mg/m^2 By Vein Over 15 Minutes x 3 Days
Procedure: Stem Cell Transplant
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yago Nieto, MD, PhD | 713-792-8750 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Yago Nieto, MD, PhD |
Principal Investigator: | Yago Nieto, MD, PhD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Yago Nieto, MD, PhD/Associate Professor ) |
Study ID Numbers: | 2007-0368 |
Study First Received: | December 20, 2007 |
Last Updated: | May 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00583622 History of Changes |
Health Authority: | United States: Institutional Review Board |
Ovarian Cancer Epithelial Ovarian Cancer Bevacizumab Carboplatin |
Gemcitabine Docetaxel Melphalan |
Antimetabolites Anti-Infective Agents Melphalan Immunologic Factors Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Bevacizumab Docetaxel Genital Diseases, Female Antibodies, Monoclonal Ovarian Cancer Gemcitabine Alkylating Agents |
Endocrine Gland Neoplasms Immunoglobulins Ovarian Neoplasms Genital Neoplasms, Female Endocrine System Diseases Carboplatin Ovarian Epithelial Cancer Angiogenesis Inhibitors Immunosuppressive Agents Antiviral Agents Antibodies Radiation-Sensitizing Agents Endocrinopathy Antineoplastic Agents, Alkylating |
Antimetabolites Anti-Infective Agents Melphalan Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Bevacizumab Genital Diseases, Female Docetaxel Neoplasms by Site |
Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Gemcitabine Alkylating Agents Endocrine Gland Neoplasms Ovarian Neoplasms Growth Substances Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Carboplatin Angiogenesis Inhibitors Antiviral Agents Immunosuppressive Agents |