Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments tipifarnib, radiation therapy
Phase phase 1
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).