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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
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00077519
First received: February 10, 2004
Last updated: February 6, 2009
Last verified: April 2007
  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 1

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Stephen Michael Hahn, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
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 Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Tipifarnib
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014