A Phase I and Pharmacokinetics Study of Docetaxel in Combination With Capecitabine and Cisplatin in Solid Tumors
Data Collection
Neoplasms
Treatment Study
Summary
Study start date: May 1, 2002
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the maximum tolerated dose of docetaxel, cisplatin, and capecitabine in patients with advanced solid tumors. * Determine the dose-limiting toxicity and recommended phase II dose of this regimen in these patients. Secondary * Determine the non-dose-limiting toxic effects associated with this regimen in these patients. * Determine the pharmacokinetics of this regimen in these patients. * Determine any clinical activity of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive docetaxel IV over 30 minutes and cisplatin IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of docetaxel, cisplatin, and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients receive treatment at the MTD. PROJECTED ACCRUAL: A minimum of 21 patients will be accrued for this study within 1.5 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.61 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.From 18 to 120 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.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor for which standard curative or palliative measures do not exist or are no longer effective * Metastatic or unresectable disease * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * More than 12 weeks Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL Hepatic * AST and ALT ≤ 2.0 times upper limit of normal (ULN) AND alkaline phosphatase \[AP\] \< ULN OR * AP ≤ 4 times ULN AND AST and ALT \< ULN * Bilirubin normal Renal * Creatinine ≤ 1.5 mg/dL OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to ingest oral medications * No allergy attributed to study drugs, compounds of similar chemical or biological composition, drugs formulated in polysorbate 80, or other agents used in this study * No inner ear auditory toxicity ≥ grade 2 * No peripheral neuropathy ≥ grade 2 * No immunodeficiency * No active or ongoing infection * No psychiatric illness or social situation that would preclude study compliance * No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent growth factors (sargramostim \[GM-CSF\] or filgrastim \[G-CSF\]) Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy and recovered Surgery * Not specified Other * No other concurrent investigational agents unless approved by the principal investigator and medical monitor * No other concurrent anticancer therapy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
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