Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00382720
Status:
COMPLETED
Last Update Posted:
2013-01-07
First Post:
2006-09-27
Brief Title:
Docetaxel and Oxaliplatin in Gastric Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Phase II Study of Docetaxel in Combination With Oxaliplatin With or Without 5-FU or Capecitabine in Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
Status:
COMPLETED
Status Verified Date:
2012-12
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 phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease Prior to this study a pilot phase I part I determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm The optimal dose was administered in the Part II study Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population
Primary objective
To assess the time to progression TTP of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil 5-FU or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease part II
Secondary objectives
To establish the safety profile
To assess the Overall Response Rate ORR based on the World Health Organization WHO criteria
To assess the Overall Survival OS
Primary objective
To assess the time to progression TTP of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil 5-FU or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease part II
Secondary objectives
To establish the safety profile
To assess the Overall Response Rate ORR based on the World Health Organization WHO criteria
To assess the Overall Survival OS
Detailed Description:
The purpose of this study Part II was to evaluate the time to progression in the 3 arms at an optimal dose level of docetaxel and oxaliplatin defined during a prior pilot Part I phase study The estimated duration of treatment was to be 6 months Treatment was to be administered up to progression unacceptable toxicities or withdrawal of consent The reason and date of removal of all participants was documented on the case report form
Participants who ended treatment but had not yet progressed eg unacceptable toxicities or withdrawal of consent were be followed every 8 weeks with a complete tumor assessment until documented progression or further anti-tumor therapy Then they would be followed every 3 months after progression for survival status date of death or progression were reported Participants who ended treatment for progression were to be followed every 3 months until death Date of death was reported The planned duration of the study was 30 months
Participants who ended treatment but had not yet progressed eg unacceptable toxicities or withdrawal of consent were be followed every 8 weeks with a complete tumor assessment until documented progression or further anti-tumor therapy Then they would be followed every 3 months after progression for survival status date of death or progression were reported Participants who ended treatment for progression were to be followed every 3 months until death Date of death was reported The planned duration of the study was 30 months
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 |
|---|---|---|---|
| EudraCT 2005-005464-92 | None | None | None |