Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064259
Status:
TERMINATED
Last Update Posted:
2021-02-17
First Post:
2003-07-08
Brief Title:
A Phase III Study of Oblimersen Plus Cisplatin and Fluorouracil in Gastric Esophageal Junction Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of Oblimersen in Combination With Cisplatin and Fluorouracil in Patients With Advanced Esophageal Gastro-Esophageal Junction and Gastric Cancer
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Discontinued development of G3139 oblimersen
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Drugs used in chemotherapy such as cisplatin and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die Oblimersen may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs This phase III trial is studying the side effects and best dose of oblimersen when given with cisplatin and fluorouracil and to see how well they work in treating patients with locally advanced recurrent or metastatic cancer of the esophagus gastroesophageal junction or stomach
Detailed Description:
PRIMARY OBJECTIVES
I The escalation portion of the study will determine the MTD of G3139Cisplatin and will help determine the toxicities of this combination
II Once the MTD is determined an additional 12 patients will be enrolled in order to obtain a set of tumor biopsies for microarray analysis
SECONDARY OBJECTIVES
I The collection of additional toxicity data for this combination
OUTLINE This is a pilot multicenter dose-escalation study of oblimersen
Phase I Patients receive oblimersen IV continuously on days 1-7 fluorouracil IV continuously on days 4-8 and cisplatin IV on day 4 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity An additional 12 patients are treated at the MTD
Phase II Patients receive treatment as in phase I with oblimersen at the MTD
PROJECTED ACCRUAL Approximately 37-97 patients 3-36 for phase I and 34-67 for phase II will be accrued for this study within 15-18 months
I The escalation portion of the study will determine the MTD of G3139Cisplatin and will help determine the toxicities of this combination
II Once the MTD is determined an additional 12 patients will be enrolled in order to obtain a set of tumor biopsies for microarray analysis
SECONDARY OBJECTIVES
I The collection of additional toxicity data for this combination
OUTLINE This is a pilot multicenter dose-escalation study of oblimersen
Phase I Patients receive oblimersen IV continuously on days 1-7 fluorouracil IV continuously on days 4-8 and cisplatin IV on day 4 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity An additional 12 patients are treated at the MTD
Phase II Patients receive treatment as in phase I with oblimersen at the MTD
PROJECTED ACCRUAL Approximately 37-97 patients 3-36 for phase I and 34-67 for phase II will be accrued for this study within 15-18 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 |
|---|---|---|---|
| 02-66 | OTHER | None | None |
| N01CM62204 | NIH | Montefiore Medical Center | httpsreporternihgovquickSearchN01CM62204 |