Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI UPCC-20203 NCI-6407, 6407, NCT00077519

Objectives

Primary

1. 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

1. Determine the 3-month clinical response in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed pancreatic cancer
  • Locally advanced disease



• Unresectable disease requiring radiotherapy

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

A total of 8-18 patients will be accrued for this study within 12-15 months.

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.

Trial Contact Information

Trial Lead Organizations

Abramson Cancer Center of the University of Pennsylvania

Stephen Michael Hahn, MD, Principal investigator		Ph: 215-662-7296 Email: hahn@xrt.upenn.edu

Registry Information
Official Title		A Phase I Trial of the Farnesyltransferase Inhibitor, R115777 (NSC# 702818) and Radiotherapy in Patients with Locally Advanced Pancreatic Cancer
Trial Start Date		2004-01-07
Registered in ClinicalTrials.gov		NCT00077519
Date Submitted to PDQ		2004-01-07
Information Last Verified		2007-04-29
NCI Grant/Contract Number		CA16520

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