Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-29 @ 7:55 AM
Study NCT ID:
NCT00005832
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2000-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S9924 R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
Study Overview
Official Title:
A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Pancreas Cancer
Status:
COMPLETED
Status Verified Date:
2015-11
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.
PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have locally advanced or metastatic pancreatic cancer.
PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have locally advanced or metastatic pancreatic cancer.
Detailed Description:
OBJECTIVES: I. Determine the six month survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777. II. Determine the time to treatment failure and confirmed response in this patient population treated with this regimen. III. Evaluate the frequency and severity of toxicities associated with this treatment regimen in these patients.
OUTLINE: Patients receive oral R115777 twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.
OUTLINE: Patients receive oral R115777 twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| S9924 | OTHER | SWOG | View | |
| U10CA032102 | NIH | None | https://reporter.nih.gov/quic… | View |