A Phase I Trial of the Farnesyltransferase Inhibitor, R115777 (NSC# 702818) and Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Phase I Trial of the Farnesyltransferase Inhibitor, R115777 (NSC# 702818) and Radiotherapy in Patients With 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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Stephen Michael Hahn, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000352182
NCT ID:
NCT00077519
Start Date:
January 2004
Completion Date:
Related Keywords:
- Pancreatic Cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- recurrent pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
