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| Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00504257 |
Purpose
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 |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer |
Biological: bevacizumab Drug: docetaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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: | September 2012 (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.
Eligibility| 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
Contacts and Locations| United States, Florida | |
| Broward General Medical Center Cancer Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Women's Cancer Associates | |
| Saint Petersburg, Florida, United States, 33701 | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, North Carolina | |
| Duke Cancer Institute | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | Robert M. Wenham, MD | H. Lee Moffitt Cancer Center and Research Institute |
More Information
| Responsible Party: | Robert M. Wenham, H. Lee Moffitt Cancer Center and Research Institute at University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00504257 History of Changes |
| Other Study ID Numbers: | CDR0000555026, MCC-14920, MCC-105366c |
| Study First Received: | July 17, 2007 |
| Last Updated: | February 7, 2012 |
| Health Authority: | United States: Federal Government |
|
recurrent ovarian epithelial cancer recurrent primary peritoneal cavity cancer recurrent fallopian tube cancer |
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms by Histologic Type Docetaxel Bevacizumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |