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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

docetaxel

ZD1839

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring High risk, adenocarcinoma, prostate cancer, neoadjuvant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Virginia Mason Medical Center

Outcomes

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

Full Information

NCT ID

NCT00242918

First Posted

October 20, 2005

Last Updated

February 3, 2012

Sponsor

Benaroya Research Institute

Collaborators

AstraZeneca, Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00242918

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2006

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Benaroya Research Institute

Collaborators

AstraZeneca, Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

High risk, adenocarcinoma, prostate cancer, neoadjuvant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

29 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

docetaxel

Intervention Type

Drug

Intervention Name(s)

ZD1839

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Evaluate the toxicity of docetaxel and ZD1839 in patients with high risk, locally advanced prostate carcinoma prior to surgical resection

Title

Clinical Response

Title

Assessment of margin of positivity at surgical resection

Title

Evaluate PSA response from baseline and post treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacqueline Vuky, MD

Organizational Affiliation

Virginia Mason Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Virginia Mason Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11577478

Citation

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. Erratum In: CA Cancer J Clin 2001 Mar-Apr;51(2):144.

Results Reference

background

PubMed Identifier

11685727

Citation

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.

Results Reference

background

PubMed Identifier

11685728

Citation

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.

Results Reference

background

PubMed Identifier

11685722

Citation

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.

Results Reference

background

PubMed Identifier

10604263

Citation

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.

Results Reference

background

PubMed Identifier

12670564

Citation

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.

Results Reference

background

PubMed Identifier

11502465

Citation

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.

Results Reference

background

PubMed Identifier

11156248

Citation

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.

Results Reference

background

PubMed Identifier

10550165

Citation

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.

Results Reference

background

PubMed Identifier

16211877

Citation

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

Results Reference

background

Links:

URL

http://www.benaroyaresearch.org

Description

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.

Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial