R115777 In Treating Patients Who Have Metastatic Pancreatic Cancer

Study Overview

R115777 in Treating Patients Who Have Metastatic Pancreatic Cancer

Phase II trial to study the effectiveness of R115777 in treating patients who have metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES: I. Determine the safety and effectiveness of R115777 in patients with metastatic pancreatic cancer. II. Determine the response rate, time to progression, and 6 month survival rate of these patients with this treatment regimen. III. Assess the pharmacokinetics of this treatment regimen in this patient population. OUTLINE: This is a multicenter study. Patients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year.

Pancreatic Cancer

DRUG: tipifarnib

NCI-2012-02335
FCCC-00005
NCI-45
CDR0000067859 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2000-06-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-02-08
First Submitted that Met QC Criteria 2004-03-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-02-11
First Posted (ESTIMATED) 2004-03-05	Results First Posted N/A	Last Verified 2007-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm I Patients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.	DRUG: tipifarnib

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm I

Patients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

DRUG: tipifarnib

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically confirmed adenocarcinoma of the pancreas
Measurable metastatic disease No prior treatment for metastatic disease except immunotherapy (e.g., antibodies, vaccines, cytokines)

Age: 18 and over
Performance status: ECOG 0-2
WBC at least 4,000/mm3 OR granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3
Bilirubin no greater than 2.0 mg/dL
SGOT/SGPT no greater than 2 times normal
Creatinine no greater than 2.0 mg/dL OR creatinine clearance at least 50 mL/min
Not pregnant or nursing
Fertile patients must use effective contraception during and for 3 months after the study
No concurrent illness or active infection which would preclude study
No prior malignancy allowed unless disease free for the time period considered appropriate for cure of the specific cancer
No history of allergies to imidazole compounds (e.g., fluconazole, ketoconazole, miconazole, itraconazole, clotrimazole)

No prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or thrombopoietin
Primary neoadjuvant or adjuvant chemotherapy allowed at least 6 months prior to detection of metastatic disease
Primary radiotherapy allowed at least 6 months prior to detection of metastatic disease
No concurrent use of proton pump inhibitors (e.g., omeprazole)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Neal J. Meropol, MD, Fox Chase Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Cohen SJ, Ho L, Ranganathan S, Abbruzzese JL, Alpaugh RK, Beard M, Lewis NL, McLaughlin S, Rogatko A, Perez-Ruixo JJ, Thistle AM, Verhaeghe T, Wang H, Weiner LM, Wright JJ, Hudes GR, Meropol NJ. Phase II and pharmacodynamic study of the farnesyltransferase inhibitor R115777 as initial therapy in patients with metastatic pancreatic adenocarcinoma. J Clin Oncol. 2003 Apr 1;21(7):1301-6. doi: 10.1200/JCO.2003.08.040.

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Clinical Trial Record