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
- 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
- Determine the non-dose-limiting toxic effects associated with this regimen in these
- 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.
- 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
- 18 and over
- ECOG 0-2
- More than 12 weeks
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8.0 g/dL
- AST and ALT ≤ 2.0 times upper limit of normal (ULN) AND alkaline phosphatase [AP] <
- AP ≤ 4 times ULN AND AST and ALT < ULN
- Bilirubin normal
- Creatinine ≤ 1.5 mg/dL OR
- Creatinine clearance ≥ 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- 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:
- No concurrent growth factors (sargramostim [GM-CSF] or filgrastim [G-CSF])
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- Not specified
- More than 4 weeks since prior radiotherapy and recovered
- Not specified
- No other concurrent investigational agents unless approved by the principal
investigator and medical monitor
- No other concurrent anticancer therapy