A Phase I, Maximum Tolerated Dose (MTD) Trial to Determine the Safety and Pharmacokinetics of Chronic Oral Administration of Farnesyl Transferase Inhibitor R115777 in Combination With Gemcitabine in Subjects With Advanced Incurable Cancer
gemcitabine hydrochloride
+ tipifarnib
Treatment Study
Summary
Study start date: October 1, 1998
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the maximum tolerated dose and dose limiting toxicities of tipifarnib in combination with gemcitabine in patients with advanced cancer. Investigate potential pharmacokinetic interactions between tipifarnib and gemcitabine in these patients. Determine the efficacy of this regimen in patients with measurable or evaluable disease. Evaluate the quality of life of these patients. OUTLINE: This is a dose-escalation study of tipifarnib. Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral tipifarnib every 12 hours beginning on day 2. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which fewer than one third of the patients experience dose limiting toxicity. Quality of life is assessed before treatment, on day 22 of each course, and at the end of treatment. PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.22 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
DISEASE CHARACTERISTICS: Pathologically proven advanced cancer for which no curative therapy exists PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin normal SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine normal Other: Unassisted oral or enteral intake sufficient to maintain a reasonable state of nutrition No concurrent medical condition that is likely to interfere with study participation No active visual disturbances that require intervention beyond corrective lenses Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No prior high dose chemotherapy with bone marrow or stem cell rescue No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy (except megestrol acetate) Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiotherapy to 25% or more of bone marrow No concurrent radiotherapy (except palliative radiotherapy within the first 28 days of the study) Surgery: Not specified Other: At least 30 days since prior investigational therapy No concurrent investigational therapy
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
San Antonio Cancer Institute
San Antonio, United StatesOpen San Antonio Cancer Institute in Google Maps