Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00191646
Status:
COMPLETED
Last Update Posted:
2011-03-04
First Post:
2005-09-12
Brief Title:
An Ovarian Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Phase III Randomized Trial of Induction Chemotherapy With Gemcitabine and Carboplatin Followed by Elective Paclitaxel Consolidation Versus Paclitaxel and Carboplatin Followed by Elective Paclitaxel Consolidation in Patients With Primary Epithelial Ovarian Primary Peritoneal Cancer or Fallopian Tube Carcinoma
Status:
COMPLETED
Status Verified Date:
2011-02
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:
This is a phase III randomized study comparing induction treatments of Gemcitabine and Carboplatin versus Paclitaxel and Carboplatin with or without consolidation therapy for patients that do not have any evidence of disease after completion of six cycles of induction therapy Patients with disease after induction therapy will crossover to receive single agent therapy
Detailed Description:
This study Study B9E-US-S302 is a multicenter comparative open-label randomized superiority trial evaluating Gemcitabine and Carboplatin to the standard of care Both treatment arms will be given the option to receive elective consolidation therapy of Paclitaxel 135 mgm2 given every 28 days for one year Patients not achieving a complete response will crossover to the opposite single agent
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| B9E-US-S302 | OTHER | Eli Lilly and Company | None |