Prostate CancerPhase 2NCT00811031
Preoperative Docetaxel for Localized Progressive Castration-resistant Prostate Cancer (CRPC)
A Phase 2 study testing Taxotere and Prednisone in people with Prostate Cancer, run by M.D. Anderson Cancer Center.
Trial summary
Objectives: Primary: To evaluate the association of the probability of increase in phosphorylation of platelet-derived growth factor receptor (PDGFR) of > 0.5 in peripheral blood leucocytes following pre-operative docetaxel chemotherapy, with progression-free survival in localized castration-resistant prostate cancer… 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?
- Taxotere and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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
- Patients with adenocarcinoma of the prostate (ductal or acinar).
- Symptomatic or evidence of progressive disease in the primary tumor by digital rectal examination, cystoscopy and/or radiological imaging without symptomatic or objective evidence of systemic disease progression.
- Patients must have a castrate serum testosterone level (</= 50ng/ml) documented in the last six weeks. For patients who are medically castrated, luteinizing hormone releasing hormone analog must continue to maintain testicular suppression.
- Patients on antiandrogens should be discontinued from flutamide, nilutamide or cyproterone acetate for at least 4 weeks and bicalutamide for 6 weeks. If localized progression is documented during or after this time interval, patients are eligible. Patients who have not had response to deferred (secondary) therapy with antiandrogens do not have to satisfy this waiting period prior to enrollment.
- Surgically resectable disease as assessed by the collaborating urological oncologist.
- Patients must be >/= 18 years of age.
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- Patients must have a performance status of </= 2 (ECOG).
- Patients must have an expected survival from cancer or co-morbidity of six months.
- Patients will not receive any concurrent biological, immunological, second-line hormonal therapy or chemotherapy. Patients receiving replacement or therapeutic doses of corticosteroid for non-malignant disease while disease progression was established may continue on such therapy.
- Patients may not have received docetaxel or other chemotherapeutic agents in the last 6 months or have been defined as docetaxel-resistant or intolerant previously.
- Patients must have adequate bone marrow function defined as an Hgb >/= 8.0 g/dl, absolute peripheral granulocyte count of >/= 1,500/mm^3 and platelet count of >/= 100,000/mm^3.
- Patients must have adequate hepatic function defined with a bilirubin of </= upper limits of normal. AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used (see chart below in Study Plan).
- Patients must have adequate renal function defined as creatinine clearance >/= 30 cc/min (measured or calculated by Cockcroft and Gault formula).
- Must be fully recovered from any previous surgery, in terms of wound healing.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.
- Men with the ability to father a child must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
Who cannot join
- Patients with severe or uncontrolled infection defined as symptomatic and/or requiring intravenous antibiotics.
- Patients with small cell or sarcomatoid variant of prostate cancer.
- Patients with symptomatic congestive heart failure (CHF), pulmonary embolus, vascular thrombosis, transient ischemic attack, cerebrovascular accident, unstable angina or MI in the last 6 months or evidence of active myocardial ischemia by symptoms or ECG.
- Oxygen-dependent lung disease, > grade 2 peripheral neuropathy, uncontrolled hypertension or uncontrolled diabetes mellitus.
- Active second malignancies. Non-threatening second malignancies such as superficial low-grade transitional cell carcinoma of the bladder, Rai Stage 0 chronic lymphocytic leukemia or stable small renal cell carcinomas may be exempt from such stipulation at the discretion of the Principal Investigator.
- Patients who are unwilling to provide blood or tissue specimens required for the primary objectives of the study.
- Overt psychosis or mental disability or otherwise incompetent to give informed consent. Patients with a history of non-compliance with medical regimens or who are considered potentially unreliable.
- Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.
About this study
Official title: A Phase II Study of Pre-operative Docetaxel for Progressive Localized Castration Resistant Prostate Cancer
Objectives:
Primary:
Read more
- To evaluate the association of the probability of increase in phosphorylation of platelet-derived growth factor receptor (PDGFR) of > 0.5 in peripheral blood leucocytes following pre-operative docetaxel chemotherapy, with progression-free survival in localized castration-resistant prostate cancer (CRPC)
Secondary:
- To evaluate the association of the probability of increase in phosphorylated platelet-derived growth factor receptor (PDGFR) expression in peripheral blood leucocytes > 0.5 with indices of tumor regression including PSA-decline by 50% and measures of objective regression of tumor by transrectal MRI following pre-operative docetaxel therapy.
- Explore associations of probability of increase in phosphorylated PDGFR in peripheral blood leucocytes following pre-operative docetaxel therapy with plasma PDGF kinetics and spatial and quantitative PDGF and phosphorylated PDGFR expression in tumor and stromal compartments in resected specimens.
- Evaluate the association of probability of increase in phosphorylated PDGFR expression in peripheral blood leucocytes following pre-operative docetaxel chemotherapy with overall survival outcomes.
- Assess global quality of life measures at baseline and 6 and 12 months post-operatively.
- Create a tissue archive comprising tumor and peripheral blood specimens as a suitable resource for future genomic and proteomic studies.
Read the detailed description
The Study Drugs:
Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It is believed to be weakly effective at killing blood vessels in cancer cells as well.
Prednisone and docetaxel are commonly used to treat prostate cancer.
Study Drug Administration:
If you are found to be eligible to take part in this study, on Day 1 of every 21-day study "cycle", you will receive docetaxel through a needle in your vein over 1 hour.
Everyday, you will take prednisone by mouth 2 times a day (in the morning and evening). You should take prednisone with meals.
You will take dexamethasone by mouth at 12 hours and 6 hours before you receive docetaxel. This is to help reduce the risk of any allergic reaction and fluid retention. It is important that you take this drug on schedule.
Study Visits:
On Day 1 of each cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight.
- Your performance status will be recorded.
- You will be asked about any drugs or treatments you may be receiving.
- You will be asked about any side effects you have experienced since your last visit.
Blood (about 2 teaspoons) will be drawn for routine tests and to test for PSA and testosterone levels.
On Day 1 of Cycle 3, blood (about 2 teaspoons) will be drawn to test for PDGFR and PDGF levels.
Surgery:
If you complete 2 cycles or more, you will be eligible to have surgery as part of this study.
If you are eligible, no more than 21 days after your last dose of docetaxel, you will have surgery to remove your prostate gland. You will sign a separate consent for this surgery, which will describe the procedure and its risks in detail.
Before surgery, probably at your pre-surgical visit, blood (about 2 teaspoons) will be drawn to test for PDGFR and PDGF levels.
Length of Study:
You will take the study drug for up to 4 cycles before having surgery. You will be off study treatment after you have surgery. You will be taken off study early if you experience intolerable side effects or the disease gets worse.
This is an investigational study. Docetaxel given with prednisone is commercially available and FDA approved for the treatment of prostate cancer.
Up to 28 participants will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Prostate Cancer
- Being tested
- Taxotere, Prednisone
- Keywords
- Prostate, prostate gland, prostate cancer markers, Taxotere®, Docetaxel, Prednisone, Castration Resistant Prostate Cancer, adenocarcinoma of the prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaxotereDrug
Also called docetaxel
75 mg/m^2 Day 1 of every 21-day cycle by vein for 4 cycles prior to surgery.
PrednisoneDrug
5 mg twice a day by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Taxotere + Prednisone | Experimental | Not described Receives: Drug: Taxotere; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-to-post chemotherapy increase phosphorylation of platelet-derived growth factor receptor (PDGFR)
Measured: PDGFR will be estimated for each patient based on blood samples taken at day 0 and at day 42 using the Bayesian survival time regression model.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
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.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Lance Pagliaro, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811031
- Sponsor's protocol ID
- 2008-0045
- Status last verified
- Jul 2012
- First submitted
- 16 Dec 2008
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pre-operative Docetaxel for Progressive Localized Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT00811031
- Acronym / sponsor ID
- 2008-0045
- Conditions
- Prostate Cancer
- Keywords
- Prostate, prostate gland, prostate cancer markers, Taxotere®, Docetaxel, Prednisone, Castration Resistant Prostate Cancer, adenocarcinoma of the prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Sanofi
- First posted
- 18 Dec 2008 (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.
Objectives:
Primary:
- To evaluate the association of the probability of increase in phosphorylation of platelet-derived growth factor receptor (PDGFR) of > 0.5 in peripheral blood leucocytes following pre-operative docetaxel chemotherapy, with progression-free survival in localized castration-resistant prostate cancer (CRPC)
Secondary:
- To evaluate the association of the probability of increase in phosphorylated platelet-derived growth factor receptor (PDGFR) expression in peripheral blood leucocytes > 0.5 with indices of tumor regression including PSA-decline by 50% and measures of objective regression of tumor by transrectal MRI following pre-operative docetaxel therapy.
- Explore associations of probability of increase in phosphorylated PDGFR in peripheral blood leucocytes following pre-operative docetaxel therapy with plasma PDGF kinetics and spatial and quantitative PDGF and phosphorylated PDGFR expression in tumor and stromal compartments in resected specimens.
- Evaluate the association of probability of increase in phosphorylated PDGFR expression in peripheral blood leucocytes following pre-operative docetaxel chemotherapy with overall survival outcomes.
- Assess global quality of life measures at baseline and 6 and 12 months post-operatively.
- Create a tissue archive comprising tumor and peripheral blood specimens as a suitable resource for future genomic and proteomic studies.
Detailed description
The Study Drugs:
Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It is believed to be weakly effective at killing blood vessels in cancer cells as well.
Prednisone and docetaxel are commonly used to treat prostate cancer.
Study Drug Administration:
If you are found to be eligible to take part in this study, on Day 1 of every 21-day study "cycle", you will receive docetaxel through a needle in your vein over 1 hour.
Everyday, you will take prednisone by mouth 2 times a day (in the morning and evening). You should take prednisone with meals.
You will take dexamethasone by mouth at 12 hours and 6 hours before you receive docetaxel. This is to help reduce the risk of any allergic reaction and fluid retention. It is important that you take this drug on schedule.
Study Visits:
On Day 1 of each cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight.
- Your performance status will be recorded.
- You will be asked about any drugs or treatments you may be receiving.
- You will be asked about any side effects you have experienced since your last visit.
Blood (about 2 teaspoons) will be drawn for routine tests and to test for PSA and testosterone levels.
On Day 1 of Cycle 3, blood (about 2 teaspoons) will be drawn to test for PDGFR and PDGF levels.
Surgery:
If you complete 2 cycles or more, you will be eligible to have surgery as part of this study.
If you are eligible, no more than 21 days after your last dose of docetaxel, you will have surgery to remove your prostate gland. You will sign a separate consent for this surgery, which will describe the procedure and its risks in detail.
Before surgery, probably at your pre-surgical visit, blood (about 2 teaspoons) will be drawn to test for PDGFR and PDGF levels.
Length of Study:
You will take the study drug for up to 4 cycles before having surgery. You will be off study treatment after you have surgery. You will be taken off study early if you experience intolerable side effects or the disease gets worse.
This is an investigational study. Docetaxel given with prednisone is commercially available and FDA approved for the treatment of prostate cancer.
Up to 28 participants will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taxotere + Prednisone | Experimental | Drug: Taxotere, Drug: Prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with adenocarcinoma of the prostate (ductal or acinar).
- Symptomatic or evidence of progressive disease in the primary tumor by digital rectal examination, cystoscopy and/or radiological imaging without symptomatic or objective evidence of systemic disease progression.
- Patients must have a castrate serum testosterone level (</= 50ng/ml) documented in the last six weeks. For patients who are medically castrated, luteinizing hormone releasing hormone analog must continue to maintain testicular suppression.
- Patients on antiandrogens should be discontinued from flutamide, nilutamide or cyproterone acetate for at least 4 weeks and bicalutamide for 6 weeks. If localized progression is documented during or after this time interval, patients are eligible. Patients who have not had response to deferred (secondary) therapy with antiandrogens do not have to satisfy this waiting period prior to enrollment.
- Surgically resectable disease as assessed by the collaborating urological oncologist.
Key exclusion criteria (8 listed)
- Patients with severe or uncontrolled infection defined as symptomatic and/or requiring intravenous antibiotics.
- Patients with small cell or sarcomatoid variant of prostate cancer.
- Patients with symptomatic congestive heart failure (CHF), pulmonary embolus, vascular thrombosis, transient ischemic attack, cerebrovascular accident, unstable angina or MI in the last 6 months or evidence of active myocardial ischemia by symptoms or ECG.
- Oxygen-dependent lung disease, > grade 2 peripheral neuropathy, uncontrolled hypertension or uncontrolled diabetes mellitus.
- Active second malignancies. Non-threatening second malignancies such as superficial low-grade transitional cell carcinoma of the bladder, Rai Stage 0 chronic lymphocytic leukemia or stable small renal cell carcinomas may be exempt from such stipulation at the discretion of the Principal Investigator.
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 |
|---|---|---|
| TaxotereAlso: docetaxel75 mg/m^2 Day 1 of every 21-day cycle by vein for 4 cycles prior to surgery. | Drug | Taxotere + Prednisone |
| Prednisone5 mg twice a day by mouth. | Drug | Taxotere + Prednisone |
Primary outcome
Pre-to-post chemotherapy increase phosphorylation of platelet-derived growth factor receptor (PDGFR)
Time frame: PDGFR will be estimated for each patient based on blood samples taken at day 0 and at day 42 using the Bayesian survival time regression model.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- UT MD Anderson Cancer Center websiteLink 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.
Lance Pagliaro, MD principal investigator
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Taxotere and Prednisone in people with Prostate Cancer, run by M.D. Anderson Cancer Center.
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 8 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: withdrawn, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Pre-to-post chemotherapy increase phosphorylation of platelet-derived growth factor receptor (PDGFR) (time frame: PDGFR will be estimated for each patient based on blood samples taken at day 0 and at day 42 using the Bayesian survival time regression model.). 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 30 Jul 2012.