Prostatic NeoplasmsPhase 2NCT00448097
Efficacy and Safety Study of Cetuximab or Cetuximab Plus Docetaxel to Treat Prostate Cancer Before Prostatectomy
A Phase 2 study testing cetuximab and docetaxel in people with Prostatic Neoplasms, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to differentiate between the administrations of Cetuximab alone vs. Cetuximab plus Docetaxel in the treatment of non-metastatic prostate cancer before the surgical 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
- Prostatic Neoplasms
- What is being tested?
- cetuximab and docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Aug 2008
- 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
- Histologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage T1c or T2a with high grade disease (Gleason's 8-10) on initial biopsy, or clinical stage T2b-T2c with Gleason's grade 7 or above with a PSA ≥ 10ng/ml, or clinical stage T3.
- Recent (< 6 weeks prior to study entry) negative bone scan and MRI of abdomen and pelvis.
- Appropriate surgical candidate for radical prostatectomy and a performance status of < 2 (Zubrod scale).
- Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count > 1,500 and platelet count of > 100,000, adequate hepatic function with a bilirubin < 1.5 mg % and SGPT < 2.5x the upper limits of normal, adequate renal function defined as serum creatinine < 1.5 x ULN.
- Patients must have normal coagulation profile (PT, PTT) and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to local use only (for control of central line patency).
- Patients must have no history of congestive heart failure or previous MI within the last 12 months.
Who cannot join
- Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational status drug.
- Unable to tolerate transrectal ultrasound.
- Patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing causes of death. Patients with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorder are not eligible. Patients with uncontrolled and symptomatic orthostatic hypotension or uncontrolled hypertension are not eligible.
- Patients who are HIV positive or have chronic hepatitis B or C infections are not eligible.
- Patients on oral steroid medications are not eligible.
- Patients with significant arteriosclerotic disease, as defined by a previous arterial bypass claudication limiting activity, or a history of cerebrovascular events within the last year (including TIA) are not eligible.
- Prior severe infusion reaction to a monoclonal antibody.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine - Methodist Hospital
Houston, Texas, 77030
About this study
Official title: A Randomized Study of Cetuximab or Cetuximab Plus Docetaxel Followed by Radical Prostatectomy for Patients With Adenocarcinoma of the Prostate
The purpose of this study is to differentiate between the administrations of Cetuximab alone vs. Cetuximab plus Docetaxel in the treatment of non-metastatic prostate cancer before the surgical removal of the prostate.
Read the detailed description
With the larger number of men who undergo screening with assays for serum prostate specific antigen, urologists continue to see considerable numbers of patients with locally advanced prostate disease. There is a higher risk of treatment failure in any patient with a tumor that extends through the prostate capsule, more aggressive pathology (Gleason score of 7 or higher), or patients with a PSA of greater than 10 ng/ml. The rationale for adding molecular targeted drugs such as Cetuximab (epithelial growth factor inhibitor), with or without chemotherapy such as Docetaxel, is that such therapy has the potential to demonstrate tumor shrinkage of the prostate and, in addition, micrometastatic cells. Cetuximab alone or Cetuximab plus Docetaxel utilizing the preprostatectomy model, with the adjuvant delivery of Cetuximab for 6 months, will provide data for the following points:
- demonstration of a PSA response prior to prostatectomy;
- demonstration whether a change in the natural history, with a delay in the onset of metastatic disease in patients with advanced local prostate cancer, can be achieved;
- laboratory and tissue correlation to assess changes in proliferative, apoptosis, and pathologic parameters; and
- metabolic imaging utilizing CT-PET with FDG to assess whether this will be a useful modality in exhibiting a response to therapy, compared with conventional radiographic imaging.
This will provide the basis for future development of neoadjuvant chemotherapy prior to prostatectomy.
- Conditions
- Prostatic Neoplasms
- Keywords
- Adenocarcinoma of the Prostate, Prostate cancer, Pre-Prostatectomy, Neoadjuvant
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabDrug
Also called Erbitux
No verifiable data available, PI relocated
docetaxelDrug
Also called Taxotere
No verifiable data available, PI relocated
| Study group | Role | What they receive |
|---|---|---|
| Data not available PI relocated | Other | No verifiable data available, PI relocated Receives: Drug: cetuximab; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response (prostate biopsy vs. prostatectomy specimen pathological evaluation): done pre-treatment vs. after prostatectomy at Week 10
No verifiable data available, PI relocated
Measured: during study
Clinical response: digital rectal exam pre-treatment and q 6 months after prostatectomy
No verifiable data available, PI relocated
Measured: during study
Secondary outcomes (4)
PSA response: tested q 3 weeks pre-prostatectomy and q 6 months post-prostatectomy
No verifiable data available, PI relocated
Measured: during study
Correlation with MRI and nuclear imaging: scans pre-treatment vs. Week 10 before surgery and yearly when PSA > 0.3
No verifiable data available, PI relocated
Measured: during study
Correlation with metabolic imaging (PET with FDG): scans pre-treatment vs. Week 10 before surgery
No verifiable data available, PI relocated
Measured: during study
Correlation with serum and plasma for antiangiogenic factors: tested q 3 weeks pre-prostatectomy
No verifiable data available, PI relocated
Measured: during study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionJun 2008
- Study completionAug 2008
Why it stopped: lack of patient population - slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Robert J Amato, DO, Principal investigator, Baylor College of Medicine - Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448097
- Sponsor's protocol ID
- HMRI IRB#0206-0027
- Other IDs
- E-VS-ET-2006
- Status last verified
- Mar 2016
- First submitted
- 14 Mar 2007
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Prewett M, Rockwell P, Rockwell RF, Giorgio NA, Mendelsohn J, Scher HI, Goldstein NI. The biologic effects of C225, a chimeric monoclonal antibody to the EGFR, on human prostate carcinoma. J Immunother Emphasis Tumor Immunol. 1996 Nov;19(6):419-27. doi: 10.1097/00002371-199611000-00006.
PubMed 9041461
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Cetuximab or Cetuximab Plus Docetaxel Followed by Radical Prostatectomy for Patients With Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT00448097
- Acronym / sponsor ID
- HMRI IRB#0206-0027
- Conditions
- Prostatic Neoplasms
- Keywords
- Adenocarcinoma of the Prostate, Prostate cancer, Pre-Prostatectomy, Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of patient population - slow accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Eli Lilly and Company
- Study start
- Feb 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Mar 2007 (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 differentiate between the administrations of Cetuximab alone vs. Cetuximab plus Docetaxel in the treatment of non-metastatic prostate cancer before the surgical removal of the prostate.
Detailed description
With the larger number of men who undergo screening with assays for serum prostate specific antigen, urologists continue to see considerable numbers of patients with locally advanced prostate disease. There is a higher risk of treatment failure in any patient with a tumor that extends through the prostate capsule, more aggressive pathology (Gleason score of 7 or higher), or patients with a PSA of greater than 10 ng/ml. The rationale for adding molecular targeted drugs such as Cetuximab (epithelial growth factor inhibitor), with or without chemotherapy such as Docetaxel, is that such therapy has the potential to demonstrate tumor shrinkage of the prostate and, in addition, micrometastatic cells. Cetuximab alone or Cetuximab plus Docetaxel utilizing the preprostatectomy model, with the adjuvant delivery of Cetuximab for 6 months, will provide data for the following points:
- demonstration of a PSA response prior to prostatectomy;
- demonstration whether a change in the natural history, with a delay in the onset of metastatic disease in patients with advanced local prostate cancer, can be achieved;
- laboratory and tissue correlation to assess changes in proliferative, apoptosis, and pathologic parameters; and
- metabolic imaging utilizing CT-PET with FDG to assess whether this will be a useful modality in exhibiting a response to therapy, compared with conventional radiographic imaging.
This will provide the basis for future development of neoadjuvant chemotherapy prior to prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data not available PI relocated | Other | Drug: cetuximab, Drug: docetaxelNo verifiable data available, PI relocated |
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)
- Histologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage T1c or T2a with high grade disease (Gleason's 8-10) on initial biopsy, or clinical stage T2b-T2c with Gleason's grade 7 or above with a PSA ≥ 10ng/ml, or clinical stage T3.
- Recent (< 6 weeks prior to study entry) negative bone scan and MRI of abdomen and pelvis.
- Appropriate surgical candidate for radical prostatectomy and a performance status of < 2 (Zubrod scale).
- Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count > 1,500 and platelet count of > 100,000, adequate hepatic function with a bilirubin < 1.5 mg % and SGPT < 2.5x the upper limits of normal, adequate renal function defined as serum creatinine < 1.5 x ULN.
- Patients must have normal coagulation profile (PT, PTT) and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to local use only (for control of central line patency).
Key exclusion criteria (7 listed)
- Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational status drug.
- Unable to tolerate transrectal ultrasound.
- Patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing causes of death. Patients with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorder are not eligible. Patients with uncontrolled and symptomatic orthostatic hypotension or uncontrolled hypertension are not eligible.
- Patients who are HIV positive or have chronic hepatitis B or C infections are not eligible.
- Patients on oral steroid medications are not eligible.
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 |
|---|---|---|
| cetuximabAlso: ErbituxNo verifiable data available, PI relocated | Drug | Data not available PI relocated |
| docetaxelAlso: TaxotereNo verifiable data available, PI relocated | Drug | Data not available PI relocated |
Primary outcome
Pathological response (prostate biopsy vs. prostatectomy specimen pathological evaluation): done pre-treatment vs. after prostatectomy at Week 10
Time frame: during study
No verifiable data available, PI relocated
Clinical response: digital rectal exam pre-treatment and q 6 months after prostatectomy
Time frame: during study
No verifiable data available, PI relocated
4 secondary outcomes
PSA response: tested q 3 weeks pre-prostatectomy and q 6 months post-prostatectomy
Time frame: during study
Correlation with MRI and nuclear imaging: scans pre-treatment vs. Week 10 before surgery and yearly when PSA > 0.3
Time frame: during study
Correlation with metabolic imaging (PET with FDG): scans pre-treatment vs. Week 10 before surgery
Time frame: during study
Correlation with serum and plasma for antiangiogenic factors: tested q 3 weeks pre-prostatectomy
Time frame: during study
Results and safety
The study was stopped early (reason given: lack of patient population - slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Background: PubMed 9041461Prewett M, Rockwell P, Rockwell RF, Giorgio NA, Mendelsohn J, Scher HI, Goldstein NI. The biologic effects of C225, a chimeric monoclonal antibody to the EGFR, on human prostate carcinoma. J Immunother Emphasis Tumor Immunol. 1996 Nov;19(6):419-27. doi: 10.1097/00002371-199611000-00006.
- Individual participant dataSharing planned: No
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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.
Robert J Amato, DO principal investigator
Baylor College of Medicine - Methodist Hospital
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 cetuximab and docetaxel in people with Prostatic Neoplasms, run by The Methodist Hospital 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 7 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: stopped early, as of the sponsor's last update on 17 Mar 2016. 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 was stopped early (reason given: lack of patient population - slow accrual). Results are not available in the source record.
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?
Pathological response (prostate biopsy vs. prostatectomy specimen pathological evaluation): done pre-treatment vs. after prostatectomy at Week 10 (time frame: during study). The study lists 2 primary outcomes in all. 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 NCT00448097, which also lists 1 linked publication.
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 17 Mar 2016.