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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2007 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on February 10, 2004. Last Updated on February 6, 2009 History of Changes

Sponsor:	University of Pennsylvania
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00077519

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: tipifarnib Radiation: radiation therapy	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Phase I Trial of the Farnesyltransferase Inhibitor, R115777 (NSC# 702818) and Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: R 115777 Tipifarnib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	18
Study Start Date:	January 2004

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077519

Locations

United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283

Sponsors and Collaborators

University of Pennsylvania

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Stephen Michael Hahn, MD

Abramson Cancer Center of the University of Pennsylvania

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00077519 History of Changes
Other Study ID Numbers:	CDR0000352182, UPCC-20203, NCI-6407
Study First Received:	February 10, 2004
Last Updated:	February 6, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases

Pancreatic Diseases
Endocrine System Diseases
Tipifarnib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012