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Spots Global Cancer Trial Database for Tipifarnib and Erlotinib Hydrochloride in Treating Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: Tipifarnib and Erlotinib Hydrochloride in Treating Patients With Advanced Solid Tumors

Official Title: Phase I Trial of R115777 and OSI-774 in Patients With Advanced Solid Tumors

Study ID: NCT00085553

Conditions

Solid Neoplasm

Study Description

Brief Summary: This phase I trial studies the side effects and best dose of tipifarnib and erlotinib hydrochloride in treating patients with solid tumors that have spread to other places in the body. Tipifarnib and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the maximal tolerated dose of R115777 (tipifarnib) in combination with OSI-774 (erlotinib hydrochloride). II. To describe the toxicity profile of this combination. III. To evaluate the effect of OSI-774 on the disposition of R115777. IV. To evaluate in vitro markers of farnesyl transferase (FT) inhibition and epidermal growth factor receptor (EGFR) inhibition. OUTLINE: This is a dose-escalation study. Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-28 (days 8-28 of course 1 as of 11/4/2013) and tipifarnib PO twice daily (BID) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. (Closed to accrual as of 2/2/06) After completion of study treatment, patients are followed up at 3 months.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mayo Clinic, Rochester, Minnesota, United States

Contact Details

Name: Julian Molina

Affiliation: Mayo Clinic

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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