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Sponsors and Collaborators: |
Massachusetts General Hospital Women and Infants Hospital of Rhode Island |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00129727 |
Study Design: This ia a Phase II study.
Subjects: Patients with chemotherapy naive epithelial ovarian cancer; or fallopian, primary peritoneal and papillary serous mullerian tumors will be recruited.
Carboplatin and Taxol (paclitaxel) will be administered concurrently with bevacizumab after surgery for 6-8 cycles every 21 (q21) days. Bevacizumab will be omitted in the first cycle, immediately post-operatively. This will be followed by one year of bevacizumab q21.
Outcomes: Outcomes include toxicity, response rate, and progression free survival.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer |
Drug: Paclitaxel Drug: Carboplatin Drug: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Evaluation of Carboplatin, Paclitaxel and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer |
Estimated Enrollment: | 51 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | August 2005 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Richard T Penson, MRCP MD | 617-726-5867 | rpenson@partners.org |
Contact: Maria Roche, NP | 617-726-5867 | mroche@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Richard T Penson, MRCP MD 617-726-5867 rpenson@partners.org | |
Contact: Maria Roche, NP 617-726-5867 mroche@partners.org | |
DF/HCC | Recruiting |
Boston, Massachusetts, United States, 02114 | |
United States, Rhode Island | |
Women and Infants | Not yet recruiting |
Providence, Rhode Island, United States, 02905 |
Principal Investigator: | Richard T Penson, MRCP MD | MGH |
Responsible Party: | Massachusetts General Hospital ( Richard Penson, MD ) |
Study ID Numbers: | 04-247 |
Study First Received: | August 10, 2005 |
Last Updated: | January 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00129727 |
Health Authority: | United States: Food and Drug Administration |
Carboplatin Paclitaxel Bevacizumab Ovarian Cancer |
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Bevacizumab Carboplatin Genital Diseases, Female Paclitaxel Endocrinopathy Endocrine Gland Neoplasms |
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 |