Status: Closed
Activation Date: 2007MAR19
Closing Date: 2009FEB13
Phase: III
Description: A Randomized, Two-Arm, Multi-Center Gynecologic Cancer Intergroup Trial of Adding Bevacizumab To Standard Chemotherapy (Carboplatin And Paclitaxel) In Patients With Epithelial Ovarian Cancer.
Eligibility: ICON7 will include patients with newly diagnosed, histologically confirmed, high risk FIGO stage I and IIa (Grade 3 or clear cell carcinoma only) and FIGO stage IIb - IV (all grades and all histological types) epithelial ovarian, fallopian tube or primary peritoneal cancer, who have undergone initial surgery (either debulking cytoreductive surgery or a biopsy if the patient has FIGO stage IV disease) and who will not be considered for cytoreductive surgery prior to disease progression. Patients with measurable and non-measurable disease (see Appendix 10) are eligible.
Objective: Primary: Progression-free survival. Secondary: Overall survival, Response rate (rate and duration), Adverse events, Quality of Life, Health Economics and Translational Research.
Participation: Open to member centres
Lay Description: The purpose of this study is to compare the effects a new drug, bevacizumab, given together with standard drugs (carboplatin and paclitaxel), which are commonly-used to treat this disease, versus being given the standard drugs alone, on you and your ovarian cancer. This research is being done because we do not know which of these two commonly-used treatments is better. Bevacizumab has been shown to improve survival in colon (bowel) cancer patients. In ovarian cancer it has been shown to shrink tumours in some women with recurrent disease, but it is not clear if it can improve the outcome of treatment in newly diagnosed ovarian cancer patients when it is added to standard chemotherapy. This study will answer that question.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GYNECOLOGIC | OV19 | 118 | 2 | 12 | 14 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GYNECOLOGIC | OV19 | 118 | 1 | 13 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| GYNECOLOGIC | OV19 | 118 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |