Safety and Effectiveness Study of Docetaxel and ZD1839 Followed by Removal of the Prostate to Treat Prostate Cancer - Full Text View

Sponsors and Collaborators:	Benaroya Research Institute AstraZeneca Sanofi-Aventis
Information provided by:	Benaroya Research Institute
ClinicalTrials.gov Identifier:	NCT00242918

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: docetaxel Drug: ZD1839	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of Neoadjuvant Docetaxel and ZD 1839 (Iressa) Followed by Radical Prostatectomy in Patients With High Risk, Locally Advanced Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docetaxel ZD1839

U.S. FDA Resources

Further study details as provided by Benaroya Research Institute:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	29
Study Start Date:	May 2003

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242918

Locations

United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101

Sponsors and Collaborators

Benaroya Research Institute

AstraZeneca

Sanofi-Aventis

Investigators

Principal Investigator:

Jacqueline Vuky, MD

Virginia Mason Medical Center

More Information

Additional Information:

Benaroya Research Institute at Virginia Mason is dedicated to discovering the causes of and cures for autoimmune and genetic diseases, to benefit patients with conditions such as diabetes, arthritis, and cancer. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Virginia Mason Medical Center is a private, non-profit organization offering a system of integrated health services. This link exits the ClinicalTrials.gov site

Publications:

Greenlee RT, Hill-Harmon MB, Murray T, Thun M. Cancer statistics, 2001. CA Cancer J Clin. 2001 Jan-Feb;51(1):15-36.

Oh WK, George DJ, Kaufman DS, Moss K, Smith MR, Richie JP, Kantoff PW. Neoadjuvant docetaxel followed by radical prostatectomy in patients with high-risk localized prostate cancer: a preliminary report. Semin Oncol. 2001 Aug;28(4 Suppl 15):40-4.

Dreicer R, Klein EA. Preliminary observations of single-agent docetaxel as neoadjuvant therapy for locally advanced prostate cancer. Semin Oncol. 2001 Aug;28(4 Suppl 15):45-8.

Pienta KJ. Preclinical mechanisms of action of docetaxel and docetaxel combinations in prostate cancer. Semin Oncol. 2001 Aug;28(4 Suppl 15):3-7. Review.

Picus J, Schultz M. Docetaxel (Taxotere) as monotherapy in the treatment of hormone-refractory prostate cancer: preliminary results. Semin Oncol. 1999 Oct;26(5 Suppl 17):14-8.

Hussain M, Smith DC, El-Rayes BF, Du W, Vaishampayan U, Fontana J, Sakr W, Wood D. Neoadjuvant docetaxel and estramustine chemotherapy in high-risk/locallyadvanced prostate cancer. Urology. 2003 Apr;61(4):774-80.

Barton J, Blackledge G, Wakeling A. Growth factors and their receptors: new targets for prostate cancer therapy. Urology. 2001 Aug;58(2 Suppl 1):114-22. Review.

Sirotnak FM, Zakowski MF, Miller VA, Scher HI, Kris MG. Efficacy of cytotoxic agents against human tumor xenografts is markedly enhanced by coadministration of ZD1839 (Iressa), an inhibitor of EGFR tyrosine kinase. Clin Cancer Res. 2000 Dec;6(12):4885-92.

Oh WK, Kantoff PW. Treatment of locally advanced prostate cancer: is chemotherapy the next step? J Clin Oncol. 1999 Nov;17(11):3664-75. Review.

Simon R. Clinical trial designs for therapeutic cancer vaccines. Cancer Treat Res. 2005;123:339-50.

Study ID Numbers:	BRI 8847, GIA #16134, 1839US/290, IIT# 16134
Study First Received:	October 20, 2005
Last Updated:	June 20, 2006
ClinicalTrials.gov Identifier:	NCT00242918 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Benaroya Research Institute:

High risk
adenocarcinoma
prostate cancer
neoadjuvant

Study placed in the following topic categories:

Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male

Adenocarcinoma
Protein Kinase Inhibitors
Gefitinib
Prostatic Neoplasms

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Enzyme Inhibitors
Urogenital Neoplasms
Genital Diseases, Male
Protein Kinase Inhibitors

Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms
Gefitinib

ClinicalTrials.gov processed this record on September 10, 2009