Clinical trial NCT00077519: Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer
Official title: A Phase I Trial of the Farnesyltransferase Inhibitor, R115777 (NSC# 702818) and Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Keywords: stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-02-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Stephen Michael Hahn, MD
role: PRINCIPAL_INVESTIGATOR
References: