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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00504257 |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to kill tumor cells or stop them from growing.
Giving bevacizumab together with docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel works in treating patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Biological: bevacizumab Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Avastin in Combination With Docetaxel in Patients With Recurrence of Epithelial Carcinoma of the Ovary/Fallopian Tube/Peritoneum Within 12 Months of Platinum Therapy |
Estimated Enrollment: | 44 |
Study Start Date: | February 2007 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Bevacizumab IV over 30-90 minutes is administered every 3 weeks (day 1 of 21-day cycle) in combination with docetaxel IV over 1 hour each week (days 1and 8 of 21-day cycle) for at least 8 courses in the absence of disease progression or toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Pathologically confirmed ovarian epithelial cancer, peritoneal serous cancer, or fallopian tube cancer
Patient may have received up to three prior chemotherapy regimens for the treatment of this malignancy
Measurable or evaluable disease either by the GOG Response Evaluation Criteria in Solid Tumors (RECIST) or CA 125 criteria
RECIST Criteria - Patients must have at least one lesion that can be accurately measured in at least one dimension with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan
CA 125 Criteria - CA 125 ≥ 70 on two occasions at least one week apart
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
AST and ALT and alkaline phosphatase must be within the following range:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
At least 3 weeks since radiotherapy, with full recovery
Exclusion criteria:
Concurrent immunotherapy or hormonal therapy for the specific purpose of treatment for the ovarian cancer
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Recruiting |
Tampa, Florida, United States, 33612-9497 | |
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese 800-456-7121 canceranswers@moffitt.org | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853 |
Principal Investigator: | Robert M. Wenham, MD | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute at University of South Florida ( Robert M. Wenham ) |
Study ID Numbers: | CDR0000555026, MCC-14920, MCC-105366c |
Study First Received: | July 17, 2007 |
Last Updated: | May 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00504257 History of Changes |
Health Authority: | Unspecified |
recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
Fallopian Tube Cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Bevacizumab Ovarian Diseases Ovarian Epithelial Cancer Abdominal Neoplasms Angiogenesis Inhibitors |
Fallopian Tube Neoplasms Recurrence Carcinoma Docetaxel Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Bevacizumab Genital Diseases, Female Docetaxel Neoplasms by Site Therapeutic Uses Peritoneal Diseases Growth Inhibitors Angiogenesis Modulating Agents Endocrine Gland Neoplasms |
Ovarian Neoplasms Digestive System Neoplasms Growth Substances Genital Neoplasms, Female Endocrine System Diseases Abdominal Neoplasms Angiogenesis Inhibitors Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Peritoneal Neoplasms |