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Phase II Trial of Neoadjuvant Docetaxel and ZD 1839 (Iressa) Followed by Radical Prostatectomy in Patients With High Risk, Locally Advanced Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Phase II Trial of Neoadjuvant Docetaxel and ZD 1839 (Iressa) Followed by Radical Prostatectomy in Patients With High Risk, Locally Advanced Prostate Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Jacqueline Vuky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Mason Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

BRI 8847

NCT ID:

NCT00242918

Start Date:

May 2003

Completion Date:

November 2007

Related Keywords:

  • Prostate Cancer
  • High risk
  • adenocarcinoma
  • prostate cancer
  • neoadjuvant
  • Prostatic Neoplasms

Name

Location
Virginia Mason Medical Center Seattle, Washington  98111