NCT00077519

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1 pancreatic-cancer

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2004

Completed
15.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

16 years

First QC Date

February 10, 2004

Last Update Submit

April 13, 2020

Conditions

Pancreatic Cancer

Keywords

stage II pancreatic cancerstage III pancreatic cancerrecurrent pancreatic cancer

Interventions

tipifarnibDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

tipifarnibRadiotherapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Stephen Michael Hahn, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2004

First Posted

February 12, 2004

Study Start

January 1, 2004

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 15, 2020

Record last verified: 2020-04

Locations

US(1)