Status: Closed
Activation Date: 2001AUG31
Closing Date: 2005JUN29
Phase: III
Description: A Phase III Study of Cisplatin Plus Topotecan Followed by Paciltaxel plus Carboplatin versus Paclitaxel plus Carboplatin as First Line Chemotherapy in Women with Newly Diagnosed Advanced Epithelial Ovarian Cancer
Eligibility: Patients with confirmed epithelial ovarian (or primary fallopian or peritoneal) cancer, Stage IIB to IV, with microscopic or macroscopic residual disease who have not received prior chemotherapy and have evidence of adequate organ function.
Objective: Primary: to compare progression free survival. Secondary: to compare overall survival, response rates, toxic effects, quality of life, and CA 125 normalization rates.
Participation: Not limited
Lay Description: The main purpose of this research study is to find out if first line treatment with four cycles of cisplatin combined with topotecan followed by another four cycles of paclitaxel combined with carboplatin will cause the tumour to shrink at least as well as, if not better than, standard treatment of paclitaxel combined with carboplatin given for eight cycles.
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Hide Tissue Samples
Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
GYNECOLOGIC | OV16 | 819 | 318 | 362 | 367 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
GYNECOLOGIC | OV16 | 819 | 9 | 301 |
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 | OV16 | 819 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |