A Phase 1 interventional study of Erlotinib Hydrochloride and Laboratory Biomarker Analysis in Solid Neoplasm, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-18.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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.
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.
National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Any of the following prior therapies:
Any of the following:
Uncontrolled intercurrent illness including, but not limited to:
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)
Drug: Erlotinib Hydrochloride · Other: Laboratory Biomarker Analysis · Other: Pharmacological Study · Drug: Tipifarnib
Given PO
Also known as: Cp-358,774, OSI-774, Tarceva
Correlative studies
Correlative studies
Given PO
Also known as: R115777, Zarnestra
Incidence of all adverse events, graded according to the National Cancer Institute Common (NCI) Terminology Criteria for Adverse Events (CTCAE) version 3.0
The number and severity of all adverse events (overall, by dose-level, and by tumor group) will be tabulated and summarized in this patient population. The grade 3+ adverse events will also be described and summarized in a similar fashion.
Time frame: Up to 30 days after last study treatment
Incidence of toxicity graded according to NCI CTCAE version 3.0
Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
Time frame: Up to 3 months
Best response as assessed by the Response Evaluation Criteria in Solid Tumors
Best Response is defined to be the best objective status recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population (overall and by tumor group).
Time frame: Start of the treatment until disease progression/recurrence, assessed up to 3 months
Time until any treatment related toxicity
Time frame: Up to 30 days after last study treatment
Time until treatment related grade 3+ toxicity
Time frame: Up to 30 days after last study treatment
Time until hematologic nadirs (white blood cells, ANC, platelets)
Time frame: Up to 3 months
Time to progression
Time frame: Up to 3 months
Time to treatment failure
Time frame: Time from registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by the patient, assessed up to 3 months
Inhibition of EGFR from tumor biopsies
Any change in these measures will be summarized descriptively within each patient and as whole group.
Time frame: Up to day 21 of course 1
Inhibition of FT from tumor biopsies
Any change in these measures will be summarized descriptively within each patient and as whole group.
Time frame: Up to day 21 of course 1
Incidence of any genetic polymorphisms
Assessed and summarized descriptively in those patients treated at the MTD.
Time frame: Up to day 21 of course 1
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)