Prostate CancerPhase 2NCT00242918
Safety and Effectiveness Study of Docetaxel and ZD1839 Followed by Removal of the Prostate to Treat Prostate Cancer
A Phase 2 study testing docetaxel and ZD1839 in people with Prostate Cancer, run by Benaroya Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- docetaxel and ZD1839
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Nov 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Mason Medical Center
Seattle, Washington, 98101
About this 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
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.
Read the 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
- Being tested
- docetaxel, ZD1839
- Keywords
- High risk, adenocarcinoma, prostate cancer, neoadjuvant
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
ZD1839Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (4)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startMay 2003
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Sanofi
- Investigators
- Jacqueline Vuky, MD, Principal investigator, Virginia Mason Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242918
- Sponsor's protocol ID
- BRI 8847
- Other IDs
- GIA #16134, 1839US/290, IIT# 16134
- Status last verified
- Jun 2006
- First submitted
- 20 Oct 2005
- Last updated
- 7 Feb 2012
- Results posted
- No
Publications
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.
PubMed 11577478Oh 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.
PubMed 11685727Dreicer 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.
PubMed 11685728Pienta 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.
PubMed 11685722Picus 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.
PubMed 10604263Hussain 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.
PubMed 12670564Barton 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.
PubMed 11502465Sirotnak 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.
PubMed 11156248Oh 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.
PubMed 10550165Simon R. Clinical trial designs for therapeutic cancer vaccines. Cancer Treat Res. 2005;123:339-50. doi: 10.1007/0-387-27545-2_14.
PubMed 16211877
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00242918
- Acronym / sponsor ID
- BRI 8847
- Conditions
- Prostate Cancer
- Keywords
- High risk, adenocarcinoma, prostate cancer, neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Collaborators
- AstraZeneca, Sanofi
- Study start
- May 2003
- Study completion
- Nov 2007 (actual)
- First posted
- 21 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxel | Drug | – |
| ZD1839 | Drug | – |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
- Background: PubMed 11577478Greenlee 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.
- Background: PubMed 11685727Oh 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.
- Background: PubMed 11685728Dreicer 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.
- Background: PubMed 11685722Pienta 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.
- Background: PubMed 10604263Picus 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.
- Background: PubMed 12670564Hussain 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.
- Background: PubMed 11502465Barton 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.
- Background: PubMed 11156248Sirotnak 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.
- Background: PubMed 10550165Oh 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.
- Background: PubMed 16211877Simon R. Clinical trial designs for therapeutic cancer vaccines. Cancer Treat Res. 2005;123:339-50. doi: 10.1007/0-387-27545-2_14.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Vuky, MD principal investigator
Virginia Mason Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel and ZD1839 in people with Prostate Cancer, run by Benaroya Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00242918, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2012.