Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003707
Status:
COMPLETED
Last Update Posted:
2012-06-28
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Cancer
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
A Phase I Maximum Tolerated Dose MTD Trial to Determine the Safety and Pharmacokinetics of Chronic Oral Administration of Farnesyl Transferase Inhibitor R115777 in Combination With Gemcitabine in Subjects With Advanced Incurable Cancer
Status:
COMPLETED
Status Verified Date:
2012-06
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 cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of combining R115777 with gemcitabine in treating patients with advanced cancer
PURPOSE Phase I trial to study the effectiveness of combining R115777 with gemcitabine in treating patients with advanced cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose limiting toxicities of tipifarnib in combination with gemcitabine in patients with advanced cancer
Investigate potential pharmacokinetic interactions between tipifarnib and gemcitabine in these patients
Determine the efficacy of this regimen in patients with measurable or evaluable disease
Evaluate the quality of life of these patients
OUTLINE This is a dose-escalation study of tipifarnib
Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 and oral tipifarnib every 12 hours beginning on day 2 Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients each receive escalating doses of tipifarnib until the maximum tolerated dose MTD is reached The MTD is defined as the dose at which fewer than one third of the patients experience dose limiting toxicity
Quality of life is assessed before treatment on day 22 of each course and at the end of treatment
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study
Determine the maximum tolerated dose and dose limiting toxicities of tipifarnib in combination with gemcitabine in patients with advanced cancer
Investigate potential pharmacokinetic interactions between tipifarnib and gemcitabine in these patients
Determine the efficacy of this regimen in patients with measurable or evaluable disease
Evaluate the quality of life of these patients
OUTLINE This is a dose-escalation study of tipifarnib
Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 and oral tipifarnib every 12 hours beginning on day 2 Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients each receive escalating doses of tipifarnib until the maximum tolerated dose MTD is reached The MTD is defined as the dose at which fewer than one third of the patients experience dose limiting toxicity
Quality of life is assessed before treatment on day 22 of each course and at the end of treatment
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA054174 | NIH | None | None |
| UTHSC-9785011335 | OTHER | None | None |
| JRF-R115777-USA-4A | OTHER | None | None |
| SACI-IDD-98-03 | OTHER | None | None |
| NCI-V98-1501 | OTHER | NCI | httpsreporternihgovquickSearchP30CA054174 |