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R115777 in Treating Patients Who Have Metastatic Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tipifarnib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the pancreas Measurable metastatic disease No prior treatment for metastatic disease except immunotherapy (e.g., antibodies, vaccines, cytokines) PATIENT CHARACTERISTICS: 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) PRIOR CONCURRENT THERAPY: 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)

Sites / Locations

  • Fox Chase Cancer Center
  • University of Texas - MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
February 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005843
Brief Title
R115777 in Treating Patients Who Have Metastatic Pancreatic Cancer
Official Title
Phase II Trial of R115777 (NSC-702818), an Inhibitor of Farnesyl Protein Transferase, in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
tipifarnib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the pancreas Measurable metastatic disease No prior treatment for metastatic disease except immunotherapy (e.g., antibodies, vaccines, cytokines) PATIENT CHARACTERISTICS: 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) PRIOR CONCURRENT THERAPY: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal J. Meropol, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12663718
Citation
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.
Results Reference
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R115777 in Treating Patients Who Have Metastatic Pancreatic Cancer

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