Trials / Completed
CompletedNCT00077519
Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer
A Phase I Trial of the Farnesyltransferase Inhibitor, R115777 (NSC# 702818) and Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- Abramson Cancer Center at Penn Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tipifarnib | |
| RADIATION | radiation therapy |
Timeline
- Start date
- 2004-01-01
- Primary completion
- 2019-12-31
- Completion
- 2019-12-31
- First posted
- 2004-02-12
- Last updated
- 2020-04-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00077519. Inclusion in this directory is not an endorsement.