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


2004-01


2019-12-31


2019-12-31


18

Study Overview

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

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.

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.

  • Pancreatic Cancer
  • DRUG: tipifarnib
  • RADIATION: radiation therapy
  • UPCC 20203
  • CDR0000352182
  • NCI-6407

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

2004-02-10  

N/A  

2020-04-13  

2004-02-11  

N/A  

2020-04-15  

2004-02-12  

N/A  

2020-04  

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:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
Secondary Outcome MeasuresMeasure DescriptionTime 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:

    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

Collaborators and Investigators

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

  • National Cancer Institute (NCI)

  • PRINCIPAL_INVESTIGATOR: Stephen Michael Hahn, MD, Abramson Cancer Center at Penn Medicine

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

No publications available