Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer
This trial is active, not recruiting.
|Treatments||tipifarnib, radiation therapy|
|Sponsor||University of Pennsylvania|
|Collaborator||National Cancer Institute (NCI)|
|Start date||January 2004|
|Trial size||18 participants|
|Trial identifier||NCT00077519, CDR0000352182, NCI-6407, UPCC-20203|
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.
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed pancreatic cancer - Locally advanced disease - Unresectable disease requiring radiotherapy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - AST or ALT < grade 2 elevation - Bilirubin ≤ 2.0 mg/dL* NOTE: *Prior biliary stent procedure to normalize bilirubin levels allowed Renal - Creatinine ≤ 1.5 times normal Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No peripheral neuropathy ≥ grade 2 - No known allergy to imidazole drugs, including any of the following: - Clotrimazole - Ketoconazole - Miconazole - Econazole - Fenticonazole - Isoconazole - Sulconazole - Tioconazole - Terconazole PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 4 weeks since prior experimental or standard chemotherapy and recovered - No concurrent experimental chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior upper abdominal radiotherapy Surgery - Not specified
|Official title||A Phase I Trial of the Farnesyltransferase Inhibitor, R115777 (NSC# 702818) and Radiotherapy in Patients With Locally Advanced Pancreatic Cancer|
|Principal investigator||Stephen Michael Hahn, MD|
|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.|
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