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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
tipifarnib
radiation therapy
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 10, 2004
Last Updated
April 13, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00077519
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tipifarnib
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Michael Hahn, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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