Phase I/II Study of Docetaxel (Taxotere) in Combination With Doxorubicin HCI Liposome Injection (Doxil) in Advanced Androgen-Independent Prostate Cancer (AIPC)
Each cycle of treatment will consist of four weeks. The 2 types of medicines are given
intravenously (in a vein). Doxil is given on the first day of each cycle. Taxotere is
given once a week for the first 3 weeks of each cycle. This is followed by a week of rest
until the next cycle starts. Treatment is given on an outpatient basis and hospitalization
is not anticipated.
Prior to entry on this study, "screening" tests are performed to determine eligibility to
participate. This will involve a complete history and physical examination, vital signs,
pain assessment, blood tests including CBC (complete blood count), serum chemistry, and PSA
(prostate specific antigen), x-rays (chest x-ray, possible plain films of bones if there are
abnormal findings on bone scan for clarification), computerized tomography (CT) scans of the
abdomen and pelvis, bone scans, a MUGA scan or 2-D echocardiogram, and a quality of life
After treatment starts the following tests are done to regularly monitor for beneficial and
toxic effect of the treatment:
Every week: blood tests.
Every month: physical examination, weight, vital signs (blood pressure, respiration,
temperature and heart rate) and PSA test.
Every 2 months: pain assessment, quality of life questionnaire, x-rays (chest x-ray and
possible pain films of bones if positive findings are seen on bone scan), computerized
tomography (CT) scans (abdomen and pelvis) and bone scans.
Participants may continue with any procedures that are part of their regular cancer care.
It is anticipated that participants will be in the study for a minimum of 2 months and as
long as they are benefiting from the treatment.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose and toxicity profile
Damian Laber, MD
James Graham Brown Cancer Center
United States: Food and Drug Administration
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