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
- 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
To assess the maximum tolerated dose of weekly taxotere, cisplatin and CPT-11 in patients with incurable solid tumor malignancies.
Charles S. Fuchs, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|