Prostate CancerPhase 2NCT00148772
Study of Erlotinib in Patients With Non-Metastatic Prostate Cancer With a Rising Prostate Specific Antigen (PSA) on Hormone Therapy
A Phase 2 study testing Erlotinib (Tarceva) in people with Prostate Cancer, run by Endeavor Health at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Erlotinib (Tarceva)
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must have documented adenocarcinoma of the prostate, treated with androgen suppression, and now present with a rising PSA .
- Prior therapy with hydrocortisone is allowed (must have discontinued > 4 weeks prior to study treatment). Prior use of ketoconazole for prostate cancer treatment is allowed (must have discontinued > 4 weeks prior to study treatment).
- Prior therapy with chemotherapy is allowed if it was administered as neoadjuvant or adjuvant therapy related to primary treatment and was completed > 6 months prior to starting study treatment.
- Testosterone level < 50 ng/dl within 4 weeks prior to study treatment. Patients who have not undergone surgical castration must continue primary androgen suppression therapy (luteinizing hormone-releasing hormone [LHRH] agonist) while on protocol therapy.
- Patients may be receiving oral bisphosphonate therapy prior to study treatment and continue while receiving treatment, but must not begin treatment with bisphosphonate while receiving study treatment. Patients on oral bisphosphonates must have completed at least 4 weeks of bisphosphonate therapy prior to study treatment.
- Patients must have adequate major organ function. All values must be obtained within 4 weeks prior to study treatment.
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- Creatinine < 1.7 mg/dL or a creatinine clearance > 50 mL/min,
- SGOT (AST), SGPT (ALT) < 2X the institution's upper limit of normal,
- Bilirubin < 1.5 mg/dL,
- ANC > 1500/mm3,
- Platelet (PLT) > 100,000/mm3
- Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Patients must be > 18.
- Patients taking warfarin are eligible.
- Patients taking CYP3A4 inducers or inhibitors are eligible.
- Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for the specific cancer.
Who cannot join
- No previous palliative radiation. Prior radiation to the primary site is allowed.
- HIV positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with erlotinib.
- Patients with gastrointestinal tract disease resulting in an inability to take oral medication are ineligible.
- Patients must not have ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements.
- Patients must not have received prior targeted therapy, including no prior EGFR inhibitor.
- Patients must not have evidence of metastatic disease.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
Evanston Northwestern Healthcare
Evanston, Illinois, 60201
About this study
Official title: Phase II Study of Erlotinib in Patients With Non-Metastatic Prostate Cancer With a Rising PSA on Hormone Therapy
The primary objective of this study is to evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy.
The secondary objectives are to evaluate the effect of erlotinib on the duration of PSA response, to evaluate the effect on the time to PSA progression, to evaluate the toxicity of erlotinib in this patient population, and lastly, to correlate the effect of erlotinib with various epidermal growth factor receptor (EGFR)-related proteins using baseline immunohistochemical (IHC) studies on tissue blocks and peripheral blood mononuclear cells.
Read the detailed description
Patients with prostate cancer who are treated with surgery or radiation often develop recurrence of their cancer which is manifest only by a rising PSA (Prostate Specific Antigen) level. Many of these patients are treated with hormone therapy. After a fall in the PSA, these patients eventually display evidence of tumor progression clearly demonstrated by another rise in PSA level while receiving hormone therapy. Evaluation for evidence of tumor spread is usually negative. There is currently no effective therapy approved for use in these patients.
The drug erlotinib works by blocking the activity of a protein called Epidermal Growth Factor Receptor (EGFR), which is located on the surface of many prostate cancer cells. Blockage of this protein has been shown to inhibit the growth of prostate tumor cells in a laboratory setting and in animal experiments. Erlotinib has been given to patients with other types of cancers. A recently completed study showed that erlotinib improved the survival of patients with advanced lung cancer who failed standard chemotherapy.
There is currently no effective therapy approved for use in patients with this condition. The purpose of this study is to evaluate the effectiveness and side effects of the drug erlotinib in patients with this condition. Erlotinib is an investigational drug that has not yet been approved by the Federal Drug Administration (FDA) for use in prostate cancer, but has been approved for use in lung cancer.
As previously stated: The primary objective of this study is to evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy.
Secondary objectives are to evaluate the effect of erlotinib on the duration of PSA response, to evaluate the effect on the time to PSA progression, to evaluate the toxicity of erlotinib in this patient population, and lastly, to correlate the effect of erlotinib with various EGFR-related proteins using baseline immunohistochemical (IHC) studies on tissue blocks and peripheral blood mononuclear cells.
- Conditions
- Prostate Cancer
- Being tested
- Erlotinib (Tarceva)
- Keywords
- Prostate Cancer, Rising PSA, Erlotinib, Tarceva, Androgen Deprivation Therapy, Hormone Therapy, Rising Prostate Specific Antigen (PSA), Non-Metastatic Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib (Tarceva)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy
Secondary outcomes (4)
To evaluate the effect of erlotinib on the duration of PSA response
To evaluate the effect of erlotinib on the time to PSA progression
To evaluate the toxicity of erlotinib in this patient population
To correlate the effect of erlotinib with various EGFR downstream proteins and androgen receptor, using baseline IHC studies on tissue blocks and analysis of protein phosphorylation in peripheral blood mononuclear cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Northwestern University
- Investigators
- Daniel Shevrin, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148772
- Sponsor's protocol ID
- OSI3316s
- Status last verified
- Aug 2005
- First submitted
- 6 Sep 2005
- Last updated
- 28 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Erlotinib in Patients With Non-Metastatic Prostate Cancer With a Rising PSA on Hormone Therapy
- ClinicalTrials.gov ID
- NCT00148772
- Acronym / sponsor ID
- OSI3316s
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Rising PSA, Erlotinib, Tarceva, Androgen Deprivation Therapy, Hormone Therapy, Rising Prostate Specific Antigen (PSA), Non-Metastatic Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- Genentech, Inc., Northwestern University
- Study start
- Aug 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 8 Sep 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 primary objective of this study is to evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy.
The secondary objectives are to evaluate the effect of erlotinib on the duration of PSA response, to evaluate the effect on the time to PSA progression, to evaluate the toxicity of erlotinib in this patient population, and lastly, to correlate the effect of erlotinib with various epidermal growth factor receptor (EGFR)-related proteins using baseline immunohistochemical (IHC) studies on tissue blocks and peripheral blood mononuclear cells.
Detailed description
Patients with prostate cancer who are treated with surgery or radiation often develop recurrence of their cancer which is manifest only by a rising PSA (Prostate Specific Antigen) level. Many of these patients are treated with hormone therapy. After a fall in the PSA, these patients eventually display evidence of tumor progression clearly demonstrated by another rise in PSA level while receiving hormone therapy. Evaluation for evidence of tumor spread is usually negative. There is currently no effective therapy approved for use in these patients.
The drug erlotinib works by blocking the activity of a protein called Epidermal Growth Factor Receptor (EGFR), which is located on the surface of many prostate cancer cells. Blockage of this protein has been shown to inhibit the growth of prostate tumor cells in a laboratory setting and in animal experiments. Erlotinib has been given to patients with other types of cancers. A recently completed study showed that erlotinib improved the survival of patients with advanced lung cancer who failed standard chemotherapy.
There is currently no effective therapy approved for use in patients with this condition. The purpose of this study is to evaluate the effectiveness and side effects of the drug erlotinib in patients with this condition. Erlotinib is an investigational drug that has not yet been approved by the Federal Drug Administration (FDA) for use in prostate cancer, but has been approved for use in lung cancer.
As previously stated: The primary objective of this study is to evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy.
Secondary objectives are to evaluate the effect of erlotinib on the duration of PSA response, to evaluate the effect on the time to PSA progression, to evaluate the toxicity of erlotinib in this patient population, and lastly, to correlate the effect of erlotinib with various EGFR-related proteins using baseline immunohistochemical (IHC) studies on tissue blocks and peripheral blood mononuclear cells.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have documented adenocarcinoma of the prostate, treated with androgen suppression, and now present with a rising PSA .
- Prior therapy with hydrocortisone is allowed (must have discontinued > 4 weeks prior to study treatment). Prior use of ketoconazole for prostate cancer treatment is allowed (must have discontinued > 4 weeks prior to study treatment).
- Prior therapy with chemotherapy is allowed if it was administered as neoadjuvant or adjuvant therapy related to primary treatment and was completed > 6 months prior to starting study treatment.
- Testosterone level < 50 ng/dl within 4 weeks prior to study treatment. Patients who have not undergone surgical castration must continue primary androgen suppression therapy (luteinizing hormone-releasing hormone [LHRH] agonist) while on protocol therapy.
- Patients may be receiving oral bisphosphonate therapy prior to study treatment and continue while receiving treatment, but must not begin treatment with bisphosphonate while receiving study treatment. Patients on oral bisphosphonates must have completed at least 4 weeks of bisphosphonate therapy prior to study treatment.
Key exclusion criteria (6 listed)
- No previous palliative radiation. Prior radiation to the primary site is allowed.
- HIV positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with erlotinib.
- Patients with gastrointestinal tract disease resulting in an inability to take oral medication are ineligible.
- Patients must not have ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements.
- Patients must not have received prior targeted therapy, including no prior EGFR inhibitor.
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 |
|---|---|---|
| Erlotinib (Tarceva) | Drug | – |
Primary outcome
To evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy
4 secondary outcomes
To evaluate the effect of erlotinib on the duration of PSA response
To evaluate the effect of erlotinib on the time to PSA progression
To evaluate the toxicity of erlotinib in this patient population
To correlate the effect of erlotinib with various EGFR downstream proteins and androgen receptor, using baseline IHC studies on tissue blocks and analysis of protein phosphorylation in peripheral blood mononuclear cells
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 28 Jun 2011.
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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.
Daniel Shevrin, MD principal investigator
Endeavor Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib (Tarceva) in people with Prostate Cancer, run by Endeavor Health at 2 sites 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 16 inclusion and 6 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 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2011.