Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer

Abramson Cancer Center at Penn Medicine18 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Pancreatic Cancer

Interventions

tipifarnibDRUG

radiation therapyRADIATION

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Data from ClinicalTrials.gov

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