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

A Phase I Trial of the Farnesyltransferase Inhibitor, R115777 (NSC# 702818) and Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00077519

Enrollment

Registered

2004-02-12

Start date

2004-01-31

Completion date

2019-12-31

Last updated

2020-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer

Brief 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.

Detailed 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.

Interventions

DRUGtipifarnib

RADIATIONradiation therapy

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026