Prostate Cancer
Conditions
Keywords
High risk, adenocarcinoma, prostate cancer, neoadjuvant
Brief summary
The purpose of this study is to determine the safety and effectiveness of the combination of docetaxel and ZD1839 on destroying prostate cancer before removal of the prostate.
Detailed description
It is recognized that there is a subset of patients who are at high risk for progression despite aggressive treatment of localized disease at the time of detection. The critical issue is in addressing micrometastatic disease that has already developed prior to diagnosis. This study utilizes daily doses of ZD1839 and weekly docetaxel for two cycles prior to radical prostatectomy. ZD1839 has demonstrated antiproliferative activity against human tumor xenografts and in coadministration with cytotoxic agents against prostate cell lines (PC-3 and TSU-PRI). The combination of ZD1839 and docetaxel has been reported to be feasible with an acceptable toxicity profile. This phase II, single center trial is specifically targeting those patients with high-risk adenosarcoma of the prostate.
Interventions
DRUGdocetaxel
DRUGZD1839
Sponsors
AstraZeneca
Sanofi
Benaroya Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* prostate carcinoma: clinical stage T2b-3 or serum PSA\>20 ng/ml or Gleason sum score 8-10. * clinical T2 patients are eligible if endorectal coil MRI shows T3 disease, or Gleason 4+3 cancer in 5 or more biopsies (minimum of 10 biopsies total required) * ECOG performance status of 0, 1 or 2 * adequate hematological, liver and renal function * existing peripheral neuropathy \< grade 1 * ability to tolerate oral medications.
Exclusion criteria
* Concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer * any major surgery within four weeks * prior hormonal therapy (except finasteride for obstructive voiding symptoms- -evidence of metastatic disease, confirmed by physical examination, computed tomography of the abdomen and pelvis within 45 days and by bone scan within 60 days of signing informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the combination of docetaxel and ZD1839 on pathologic complete response (pCR) in radical prostatectomy specimens. Pathological complete response is defined as no microscopic evidence of neoplastic cells in the resected specimen. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the toxicity of docetaxel and ZD1839 in patients with high risk, locally advanced prostate carcinoma prior to surgical resection | — |
| Clinical Response | — |
| Assessment of margin of positivity at surgical resection | — |
| Evaluate PSA response from baseline and post treatment | — |
Countries
United States
Outcome results
None listed