Clinical trial · Interventional
Tipifarnib and Erlotinib Hydrochloride in Treating Patients With Advanced Solid Tumors
Phase I Trial of R115777 and OSI-774 in Patients With Advanced Solid Tumors
NCT00085553CI-TRIAL-00033000completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Neoplasm | Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib Hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
| Tipifarnib | Drug | Tipifarnib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (erlotinib hydrochloride, tipifarnib)
- description
- 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)
- interventionNames
- Drug: Erlotinib Hydrochloride
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- Drug: Tipifarnib
Primary outcomes (2)
- measure
- Incidence of all adverse events, graded according to the National Cancer Institute Common (NCI) Terminology Criteria for Adverse Events (CTCAE) version 3.0
- timeFrame
- Up to 30 days after last study treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic proof of cancer that is unresectable and for which no standard life-prolonging therapy is available * Absolute neutrophil count (ANC) \>= 1500/uL * Platelet count (PLT) \>= 100,000/uL * Total bilirubin =\< 2 mg/dL * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) * Creatinine =\< 1.5 x ULN * Hemoglobin (Hgb) \>= 9.0 g/dL * Ability to provide informed consent * Willingness to return to Mayo Clinic Rochester for follow up * Life expectancy \>= 12 weeks * At maximum tolerated dose (MTD) only: tumor that is amenable for serial biopsy * Medically capable and willing to provide the biologic specimens as required by the protocol Note: The goals of this study include assessment of the biologic effects on surrogate markers of the agent(s) being tested and are, therefore, contingent upon availability of the biologic specimens; patients with pre-existing clinical contraindications (e.g. anticoagulant therapy) for biopsy will be excluded from participation in the study; however, those patients who develop a major complication associated with the first biopsy (e.g. bleeding) or who develop clinical contraindications (e.g., anticoagulant therapy) after entry on study may remain on the study without the requirement for further tissue biopsies; this stipulation only applies to the 12 patients enrolled in Cohort II at MTD; the stipulation for provision of biologic specimens, as noted above, excludes the optional pharmacogenomic specimen Exclusion Criteria: * Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2, 3, or 4 * Uncontrolled infection * Any of the following prior therapies: * Chemotherapy =\< 4 weeks prior to study entry * Mitomycin C/nitrosoureas =\< 6 weeks prior to study entry * Immunotherapy =\< 4 weeks prior to study entry * Biologic therapy =\< 4 weeks prior to study entry * Hormonal cancer therapy =\< 4 weeks prior to study entry * Radiation therapy =\< 4 weeks prior to study entry * Radiation to \> 25% of bone marrow * Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment * New York Heart Association classification III or IV * Patients on enzyme-inducing anticonvulsants (Phenobarbital, Dilantin, or Tegretol) * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms plus spermicidal agents, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.) * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation) * Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements * Prior treatment with EGFR targeting therapies (e.g., ZD-1869, EKB-569, OSI-774, CI-1033, GW572016, C225, EMD72000) or Farnesyl transferase inhibitors (R115777, SCH66336, BMS2146632) * Major surgery, or significant traumatic injury occurring =\< 21 days prior to study entry * Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjögren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test) * Gastrointestinal tract disease resulting in an inability to take oral or nasogastric medication or a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease * Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy * Known brain metastases unless treated with surgery and/or radiation and stable for \>= 8 weeks; patient should not be on enzyme-inducing anticonvulsants (Phenobarbital, Phenytoin (Dilantin) or Carbamazepine (Tegretol))
References
Publications (0)
Data not yet available
No reference posted for this study.