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.

Condition	Treatment or Intervention	Phase
stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer	Drug: tipifarnib  Procedure: enzyme inhibitor therapy  Procedure: radiation therapy  Procedure: radiosensitization	Phase I

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Pennsylvania
      Abramson Cancer Center at the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting

Study chairs or principal investigators

Stephen Michael Hahn, MD,  Principal Investigator,  University of Pennsylvania Cancer Center   

Study ID Numbers:  CDR0000352182; UPCC-20203; NCI-6407; NCT00077519
Record last reviewed:  June 2004
Last Updated:  April 5, 2005
Record first received:  February 10, 2004
ClinicalTrials.gov Identifier:  NCT00077519
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08