Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00077519|
Recruitment Status : Unknown
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 12, 2004
Last Update Posted : February 9, 2009
|First Submitted Date ICMJE||February 10, 2004|
|First Posted Date ICMJE||February 12, 2004|
|Last Update Posted Date||February 9, 2009|
|Study Start Date ICMJE||January 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00077519 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer|
|Official Title ICMJE||A Phase I Trial of the Farnesyltransferase Inhibitor, R115777 (NSC# 702818) and Radiotherapy in Patients With Locally Advanced Pancreatic Cancer|
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.
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 Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Pancreatic Cancer|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE
|Original Enrollment ICMJE||Not Provided|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00077519|
|Other Study ID Numbers ICMJE||CDR0000352182
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Pennsylvania|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||April 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP