Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107341
Status:
COMPLETED
Last Update Posted:
2016-12-13
First Post:
2005-04-05
Brief Title:
Bortezomib Paclitaxel and Carboplatin in Treating Patients With Unresectable Metastatic Cancer of the Esophagus or Gastroesophageal Junction
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for Metastatic Adenocarcinoma of the Lower Esophagus Gastroesophageal Junction and Gastric Cardia
Status:
COMPLETED
Status Verified Date:
2016-12
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:
RATIONALE Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as paclitaxel and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving bortezomib together with paclitaxel and carboplatin may kill more tumor cells
PURPOSE This phase II trial is studying how well giving bortezomib together with paclitaxel and carboplatin works in treating patients with unresectable metastatic cancer of the esophagus or gastroesophageal junction
PURPOSE This phase II trial is studying how well giving bortezomib together with paclitaxel and carboplatin works in treating patients with unresectable metastatic cancer of the esophagus or gastroesophageal junction
Detailed Description:
OBJECTIVES
Primary
Determine the confirmed tumor response rate in patients with unresectable metastatic adenocarcinoma of the esophagus gastroesophageal junction or gastric cardia treated with bortezomib paclitaxel and carboplatin
Secondary
Determine the time to tumor progression overall survival and duration of response in patients treated with this regimen
Determine the adverse events in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months until disease progression and then every 6 months for up to 3 years
PROJECTED ACCRUAL A total of 25-60 patients will be accrued for this study within 17 months
Primary
Determine the confirmed tumor response rate in patients with unresectable metastatic adenocarcinoma of the esophagus gastroesophageal junction or gastric cardia treated with bortezomib paclitaxel and carboplatin
Secondary
Determine the time to tumor progression overall survival and duration of response in patients treated with this regimen
Determine the adverse events in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months until disease progression and then every 6 months for up to 3 years
PROJECTED ACCRUAL A total of 25-60 patients will be accrued for this study within 17 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 |
|---|---|---|---|
| NCI-2012-02646 | REGISTRY | None | None |
| CDR0000413896 | REGISTRY | PDQ Physician Data Query | None |