Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077519
Status:
COMPLETED
Last Update Posted:
2020-04-15
First Post:
2004-02-10
Brief Title:
Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
A Phase I Trial of the Farnesyltransferase Inhibitor R115777 NSC 702818 and Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and may make them more sensitive to radiation therapy Radiation therapy uses high-energy x-rays to damage tumor cells Giving tipifarnib together with radiation therapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of tipifarnib when given together with radiation therapy in treating patients with unresectable locally advanced pancreatic cancer
PURPOSE This phase I trial is studying the side effects and best dose of tipifarnib when given together with radiation therapy in treating patients with unresectable locally advanced pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and dose-limiting toxic effects of tipifarnib when administered with radiotherapy in patients with unresectable locally advanced pancreatic cancer
Secondary
Determine the 3-month clinical response in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of tipifarnib
Patients receive oral tipifarnib once or twice daily on weeks 1-8 Patients also undergo concurrent radiotherapy daily 5 days a week on weeks 2-8
Cohorts of 3-6 patients receive escalating doses of tipifarnib 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
Patients are followed at 1 3 and 6 months
PROJECTED ACCRUAL A total of 8-18 patients will be accrued for this study within 12-15 months
Primary
Determine the maximum tolerated dose and dose-limiting toxic effects of tipifarnib when administered with radiotherapy in patients with unresectable locally advanced pancreatic cancer
Secondary
Determine the 3-month clinical response in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of tipifarnib
Patients receive oral tipifarnib once or twice daily on weeks 1-8 Patients also undergo concurrent radiotherapy daily 5 days a week on weeks 2-8
Cohorts of 3-6 patients receive escalating doses of tipifarnib 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
Patients are followed at 1 3 and 6 months
PROJECTED ACCRUAL A total of 8-18 patients will be accrued for this study within 12-15 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-6407 | None | None | None |
| CDR0000352182 | None | None | None |