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. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining docetaxel and capecitabine with cisplatin in treating patients who have metastatic or unresectable solid tumors.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: capecitabine  Drug: cisplatin  Drug: docetaxel  Procedure: chemotherapy	Phase I

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

Study chairs or principal investigators

Marwan Fakih, MD,  Principal Investigator,  Roswell Park Cancer Institute   

Study ID Numbers:  CDR0000365571; RPCI-RPC-0209; NCT00084734
Record last reviewed:  February 2005
Last Updated:  February 17, 2005
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00084734
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08