Tipifarnib and Erlotinib Hydrochloride in Treating Patients With Advanced Solid Tumors

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00085553
Phase
PHASE1
Status
Completed

Conditions

  • Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib Hydrochloride — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Tipifarnib — DRUG
    Given PO

Study Details

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.

Key Dates

First listed
Jun 11, 2004
Start date
May 20, 2004
Status verified
May 2018
Primary completion
May 7, 2008
Completion
May 16, 2018

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (erlotinib hydrochloride, tipifarnib)
    Patients receive erlotinib hydrochloride PO QD on days 1-28 (days 8-28 of course 1 as of 11/4/2013) and tipifarnib PO 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)

Primary Outcome Measure

Incidence of all adverse events, graded according to the National Cancer Institute Common (NCI) Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 30 days after last study treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

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