Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127920
Status:
COMPLETED
Last Update Posted:
2015-03-10
First Post:
2005-08-05
Brief Title:
Pilot Study of Taxol Carboplatin and Bevacizumab in Advanced Stage Ovarian Carcinoma Patients
Sponsor:
Gynecologic Oncology Associates
Organization:
Gynecologic Oncology Associates
Study Overview
Official Title:
A Phase II Open-Label Non-Randomized Multi-Center Pilot Study of Intravenous Taxol Carboplatin Bevacizumab Given Every 21 Days in Patients With Newly Diagnosed Stage IIIIV Epithelial Ovarian Fallopian Tube or Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The most likely way to improve survival and cure rates in treating ovarian cancer fallopian tube epithelial cancer and peritoneal cancer is with maximal upfront therapy Morrow Curtin 1998 This involves an optimal primary tumor debulking surgery The most active chemotherapy agents should then be promptly administered Taxol and Carboplatin or Cisplatin have become the standard first line therapy because of proven survival benefits with those regimens in treating advanced ovarian adenocarcinoma patients New chemotherapy agents like bevacizumab have demonstrated increased overall and progression free survival benefits in metastatic colorectal cancer patients and are being studied for their potential contributory impact on the current standard of treatment Since no triplet regimen has demonstrated compelling superiority the combination of taxol carboplatin and bevacizumab is intriguing because of their potential synergy distinct mechanisms of action and non-overlapping toxicity
The null hypothesis Ho is that the drug regimen will demonstrate an 80 patient response rate RR
The alternative Hypothesis H1 The triplet drug regimen will demonstrate a significantly higher patient response rate than standard therapy
Hypothesis H2 The triplet drug regimen will demonstrate a significantly more favorable patient time to tumor progression rate than standard therapy
The null hypothesis Ho is that the drug regimen will demonstrate an 80 patient response rate RR
The alternative Hypothesis H1 The triplet drug regimen will demonstrate a significantly higher patient response rate than standard therapy
Hypothesis H2 The triplet drug regimen will demonstrate a significantly more favorable patient time to tumor progression rate than standard therapy
Detailed Description:
The most likely way to improve survival and cure rates in treating ovarian cancer fallopian tube epithelial cancer and peritoneal cancer is with maximal upfront therapy This involves an optimal primary tumor debulking surgery The most active chemotherapy agents should then be promptly administered Taxol and Carboplatin or Cisplatin have become the standard first line therapy because of proven survival benefits with those regimens in treating advanced ovarian adenocarcinoma patients New agents like bevacizumab Avastin which have demonstrated increased overall and progression free survival benefits in metastatic colorectal cancer patients are being added to the optimal first line ovarian chemotherapy regimen in hopes of seeing improvement in progressive free interval and over-all survival Since no triplet regimen has demonstrated compelling superiority the combination of taxol carboplatin and bevacizumab Avastin is intriguing because of their potential synergy distinct mechanisms of action and non-overlapping toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None