Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004127
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
1999-12-10
Brief Title:
Oxaliplatin Combined With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase II Study of Oxaliplatin in Combination With Fluorouracil and Leucovorin in Carcinoma of the Esophagus and Gastric Cardia
Status:
COMPLETED
Status Verified Date:
2013-02
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining oxaliplatin with fluorouracil and leucovorin in treating patients who have recurrent or metastatic cancer of the esophagus or stomach
PURPOSE Phase II trial to study the effectiveness of combining oxaliplatin with fluorouracil and leucovorin in treating patients who have recurrent or metastatic cancer of the esophagus or stomach
Detailed Description:
OBJECTIVES I Determine the response rate in patients with recurrent or metastatic carcinoma of the esophagus or gastric cardia receiving the combination of oxaliplatin fluorouracil and leucovorin calcium II Determine the duration of response and overall survival of this patient population receiving this regimen III Determine the toxicity including neurotoxicity of this regimen in this patient population
OUTLINE This is an open-label multicenter study Patients receive oxaliplatin IV over 2 hours on day 1 then leucovorin calcium IV over 2 hours with fluorouracil IV bolus followed by fluorouracil IV over 22 hours on days 1 and 2 Treatment continues every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease receive at least 3 additional courses of therapy Patients are followed for a minimum of 2 years or until death
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study over 18 months
OUTLINE This is an open-label multicenter study Patients receive oxaliplatin IV over 2 hours on day 1 then leucovorin calcium IV over 2 hours with fluorouracil IV bolus followed by fluorouracil IV over 22 hours on days 1 and 2 Treatment continues every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease receive at least 3 additional courses of therapy Patients are followed for a minimum of 2 years or until death
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study over 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 |
|---|---|---|---|
| NCI-T99-0010 | None | None | None |
| UCCRC-10015 | None | None | None |