Docetaxel, Capecitabine, and Cisplatin in Treating Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as docetaxel, capecitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel, capecitabine, and cisplatin in treating patients with metastatic or unresectable solid tumors.

Detailed Description
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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.

Official Title
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A Phase I and Pharmacokinetics Study of Docetaxel in Combination With Capecitabine and Cisplatin in Solid Tumors

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: capecitabine
* Drug: cisplatin
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: capecitabine|Oral|
|Drug: cisplatin|IV|
|Drug: docetaxel|IV|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the maximum tolerated dose of docetaxel, cisplatin, and capecitabine in patients with advanced solid tumors. |  | Every 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the non-dose-limiting toxic effects associated with this regimen in these patients |  | Every 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific