Tipifarnib and Erlotinib Hydrochloride in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00085553|
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Solid Neoplasm||Drug: Erlotinib Hydrochloride Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Tipifarnib||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of R115777 and OSI-774 in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||May 20, 2004|
|Actual Primary Completion Date :||May 7, 2008|
|Actual Study Completion Date :||May 16, 2018|
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)
Drug: Erlotinib Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- 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 ]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.
- Incidence of toxicity graded according to NCI CTCAE version 3.0 [ Time Frame: Up to 3 months ]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.
- Best response as assessed by the Response Evaluation Criteria in Solid Tumors [ Time Frame: Start of the treatment until disease progression/recurrence, assessed up to 3 months ]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 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 [ Time Frame: Up to day 21 of course 1 ]Any change in these measures will be summarized descriptively within each patient and as whole group.
- Inhibition of FT from tumor biopsies [ Time Frame: Up to day 21 of course 1 ]Any change in these measures will be summarized descriptively within each patient and as whole group.
- Incidence of any genetic polymorphisms [ Time Frame: Up to day 21 of course 1 ]Assessed and summarized descriptively in those patients treated at the MTD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085553
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Julian Molina||Mayo Clinic|