Safety and Effectiveness Study of Docetaxel and ZD1839 Followed by Removal of the Prostate to Treat Prostate Cancer

NCT ID: NCT00242918

Last Updated: 2012-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2007-11-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

Intervention Type: DRUG

ZD1839

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

Benaroya Research Institute

OTHER

Sponsor Role: lead

Principal Investigators

Jacqueline Vuky, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center

Locations

Virginia Mason Medical Center

Seattle, Washington, United States

Countries

United States

References

Greenlee RT, Hill-Harmon MB, Murray T, Thun M. Cancer statistics, 2001. CA Cancer J Clin. 2001 Jan-Feb;51(1):15-36. doi: 10.3322/canjclin.51.1.15.

Reference Type: BACKGROUND

PMID: 11577478 (View on PubMed)

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. doi: 10.1016/s0093-7754(01)90153-8.

Reference Type: BACKGROUND

PMID: 11685727 (View on PubMed)

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. doi: 10.1016/s0093-7754(01)90154-x.

Reference Type: BACKGROUND

PMID: 11685728 (View on PubMed)

Pienta KJ. Preclinical mechanisms of action of docetaxel and docetaxel combinations in prostate cancer. Semin Oncol. 2001 Aug;28(4 Suppl 15):3-7. doi: 10.1016/s0093-7754(01)90148-4.

Reference Type: BACKGROUND

PMID: 11685722 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10604263 (View on PubMed)

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. doi: 10.1016/s0090-4295(02)02519-0.

Reference Type: BACKGROUND

PMID: 12670564 (View on PubMed)

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. doi: 10.1016/s0090-4295(01)01253-5.

Reference Type: BACKGROUND

PMID: 11502465 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11156248 (View on PubMed)

Oh WK, Kantoff PW. Treatment of locally advanced prostate cancer: is chemotherapy the next step? J Clin Oncol. 1999 Nov;17(11):3664-75. doi: 10.1200/JCO.1999.17.11.3664.

Reference Type: BACKGROUND

PMID: 10550165 (View on PubMed)

Simon R. Clinical trial designs for therapeutic cancer vaccines. Cancer Treat Res. 2005;123:339-50. doi: 10.1007/0-387-27545-2_14.

Reference Type: BACKGROUND

PMID: 16211877 (View on PubMed)

Related Links

http://www.benaroyaresearch.org

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.

Other Identifiers

GIA #16134

Identifier Type: -

Identifier Source: secondary_id

1839US/290

Identifier Type: -

Identifier Source: secondary_id

IIT# 16134

Identifier Type: -

Identifier Source: secondary_id

BRI 8847

Identifier Type: -

Identifier Source: org_study_id