Trial Information

Phase I Study of 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.