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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

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 PennsylvaniaPhiladelphia, Pennsylvania  19104-4283