Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies

• This is a Phase I clinical trial. We are unsure of the safest and most effective dose of the drugs and therefore are planning on treating 3-6 patients with a given dose before increasing to higher dose levels.
• Each patient will receive approximately two cycles of therapy. On day one and day eight, they will receive taxotere, cisplatin and CPT-11 intravenously. The cycle will begin again on day 22.
• The following tests and procedures will be performed: CAT scan prior to beginning therapy, after every 2 cycles of therapy, and at the end of the study; physical exam before each course of therapy; vital signs before and with each dose of therapy; routine blood tests before starting therapy and weekly during treatment; chest x-ray and echocardiogram before starting therapy and; toxicity assessment each week of therapy.
• Patients will remain on the study as long as their cancer responds to treatment and they do not have unacceptable side effects.

Inclusion criteria

• Histologically confirmed, incurable solid tumor malignancy
• 18 years of age or older
• ECOG performance status of < or = to 2
• Life expectancy of greater than 12 weeks
• WBC > 3,000/mm3
• ANC > 1,500/mm3
• Platelet count > 100,000/mm3
• Total bilirubin within normal limits
• SGOT < 2.5 x ULN
• Alkaline phosphatase < 4 x ULN

Exclusion criteria

• Prior chemotherapy for the treatment of metastatic or recurrent cancer
• Prior radiotherapy to greater than or equal to 15% of bone marrow
• Prior pelvic radiation therapy
• Prior nitrosoureas or mitomycin C
• Myocardial infarction in the past 6 months
• Major surgery in past 2 weeks
• Uncontrolled serious medical or psychiatric illness
• Uncontrolled diarrhea
• Peripheral neuropathy > grade 1
• Pregnant or lactating women
• Clinically apparent central nervous system metastases or carcinomatous meningitis