Solid Tumor Clinical Trial
Official title:
Phase I Study of Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies
The purpose of this study is to find the highest dose of the combination of taxotere, cisplatin and CPT-11, that can be given without causing severe side effects. We also want to test the safety of this drug combination and see what effects (good and bad) it has on patients with advanced cancer for which there is no known curable treatment.
- 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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