Prostate CancerPhase 1NCT00631527
Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer
A Phase 1 study testing Leuprolide, Goserelin and Sunitinib Malate in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn the safety of adding 3 different dose-levels of Sutent® (sunitinib malate) to a combination of hormone therapy and radiation in patients with 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?
- Leuprolide, Goserelin and Sunitinib Malate
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2015
- Phase
- Phase 1
- 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
- Adenocarcinoma of the prostate with the following high-risk features are eligible: clinical T2c, clinical or pathological T3 or T4 disease OR Gleason 8-10 disease OR PSA > 20ng/ml.
- Patients must have no evidence of metastatic disease by clinical and radiological staging including Chest X-ray, Bone scan and CT Scan of the Abdomen and Pelvis.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Calculated Creatinine clearance > 35cc/min, Absolute neutrophil count > 1,500/mm^3, Platelets >/= 100,000/mm^3, AST/ALT < 2.5 x upper normal limit (UNL), Total bilirubin within normal limits (WNL).
- No standard contraindications to radiation therapy including prior radiation therapy, inflammatory bowel disease, irritable bowel syndrome, or and collagen vascular disease.
- Patients must be at least 18 years of age
- Patients may have had up to 8 weeks of hormonal therapy defined as luteinizing-hormone releasing hormone or other medical castration therapy prior to registration.
Who cannot join
- Prior VEGFR/PDGFR inhibitor or other investigational therapy.
- Inability to take oral medication
- Chronically uncontrolled hypertension, defined conventionally as consistent/repeated systolic pressures above 140 mmHg or diastolic pressures above 90 mmHg despite anti-hypertensive therapy. This may be established with home BP readings. There is no criterion related to a specific BP result required for eligibility, nor are acute BP elevations that are related to iatrogenic causes, acute pain, or other transient reversible causes considered an exclusion criteria. The intent is to exclude patients with chronically uncontrolled hypertension that might be further exacerbated by Sunitinib.
- Left Ventricular Ejection Fraction </= 40%, symptomatic congestive heart failure or symptomatic ischemic heart disease, deep venous thrombosis or pulmonary embolism in the last 12 months.
- Known human immunodeficiency virus infection, alcoholism, chronic active hepatitis or liver cirrhosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer
The goal of this clinical research study is to learn the safety of adding 3 different dose-levels of Sutent® (sunitinib malate) to a combination of hormone therapy and radiation in patients with prostate cancer.
Read the detailed description
The Study Drugs:
Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.
Luteinizing Hormone-Releasing Hormone (LHRH) Analogues like Lupron® (leuprolide) and Zoladex® (goserelin) are hormonal treatments used to help stop the body from making testosterone (male sex hormones) in the body. Prostate cancer cells need testosterone to survive.
Anti-Androgen drugs, like Casodex® (bicalutamide) also stop cell growth by blocking male hormones like testosterone.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will be assigned to a study group. The group you are assigned to and dose of sunitinib malate you receive will depend on when you join this study. Three (3) dose levels of sunitinib malate will be tested. The first group of participants will receive the lowest dose of sunitinib malate. The next group enrolled will receive a higher dose of sunitinib malate, if no intolerable side effects were seen.
Before you begin taking sunitinib, you will begin receiving hormone therapy. You will receive leuprolide or goserelin. Leuprolide is given through a needle in your muscle, and goserelin is given through a needle under the skin in the abdomen. You will receive 1 of these injections every 3 months. Which hormonal drug you are given (leuprolide or goserelin) will be assigned by your doctor and/or will depend on your insurance coverage.
You may also receive bicalutamide. This will be left up to the doctor. You will take bicalutamide by mouth once a day for 2 weeks (with or without food).
After at least 4 weeks of hormone therapy have been given, you will begin taking sunitinib malate in combination with the hormone therapy. You will take sunitinib malate once a day (either with or without food) for 16 weeks in a row.
Radiation Therapy:
After 4 weeks of combined treatment with sunitinib and hormone therapy, you will begin radiation treatments. Radiation treatments will be given once a day, 5 days a week, for about 8 weeks. Each treatment will take 20-30 minutes. This procedure will be discussed with you in more detail. You will continue taking sunitinib and hormone therapy while you are on radiation treatments.
Study Visits:
On the day you start treatment with sunitinib, you will have the following tests and procedures performed:
- You will have a physical exam, including measurements of your blood pressure and weight.
- You will be asked about any side effects you may have had since your last visit.
- Blood (about 1 teaspoon) will be drawn for routine tests.
About Day 15 of treatment with sunitinib, and on the day you begin radiation therapy (before your first treatment), you will have the following tests and procedures performed:
- You will have a physical exam, including measurements of your blood pressure and weight.
- You will be asked about any side effects you may have had since your last visit.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Every 2 weeks during radiation therapy, you will have the following tests and procedures performed:
- You will have a physical exam, including measurements of your blood pressure and weight (every 2 weeks)
- You will have blood drawn (about 2 teaspoons) for routine testing.
- You will be asked about any side effects you may have had since your last visit.
About 4 weeks after you stop radiation therapy, you will have the following test and procedures performed:
- You will have a physical exam, including measurements of your blood pressure and weight.
- Blood (about 2 teaspoons) and urine will be collected for routine tests. The blood testing will include measurement of prostatic specific antigen (PSA) and testosterone levels.
- You will be asked about any side effects you have had since your last visit.
Length of Study:
You will continue taking sunitinib malate on this study for a total of 16 weeks. Radiation treatments will last for up to 8 weeks. Hormone injections will continue for a period of 2 years. You will be taken off this study if intolerable side effects occur or the disease gets worse.
Long-Term Follow-up:
You will be followed every 6 months via telephone call and/or a review of your medical record. If contacted, you will be asked about any side effects you have had, or therapies you may have had since stopping treatment on this study. You will be followed for up to 10 years once you have taken sunitinib malate for 20 weeks.
This is an investigational study. Sunitinib malate is FDA approved and commercially available for the treatment of adults with kidney cancer.
Bicalutamide, leuprolide, and goserelin are FDA approved and commercially available for use in prostate cancer.
Up to 22 patients will be enrolled in this multicenter trial. Up to 12 will be enrolled at MD Anderson.
- Conditions
- Prostate Cancer
- Being tested
- Leuprolide, Goserelin, Sunitinib Malate, Casodex, Radiation Therapy (RT)
- Keywords
- Prostate Cancer, Radiation Therapy, RT, Radiotherapy, Hormone Ablation, Sunitinib Malate, Leuprolide, Lupron, Zoladex, Goserelin, Casodex, Bicalutamide, SU011248, Sutent, Angiogenesis inhibitor
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeuprolideDrug
Also called Lupron
Injections given through a needle in the muscle every 3 months.
GoserelinDrug
Also called Zoladex
Subcutaneous injections given once every 3 months.
Sunitinib MalateDrug
Also called SU011248, Sutent
Starting dose of 12.5 mg by mouth daily for 4 weeks
CasodexDrug
Also called Bicalutamide
Once a day by mouth for 2 weeks.
Radiation Therapy (RT)Radiation
Also called Radiotherapy
Radiation treatment once daily over a period of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib Malate, Hormone Ablation + RT | Experimental | Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT) Receives: Drug: Leuprolide; Drug: Goserelin; Drug: Sunitinib Malate; Drug: Casodex; Radiation: Radiation Therapy (RT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) as defined by Dose Limiting Toxicity (DLT)
DLT defined as inability to complete the schedule course of radiation therapy for toxicity of any grade. If < 2 patients in initial cohort of 6 experience DLT then a subsequent dose-level cohort initiated. If 2 or more patients in a cohort experience DLT then further accrual to that cohort curtailed and no higher dose level examined. Maximum tolerated dose (MTD) for oral sunitinib in combination with radiation and hormone ablation defined as highest dose level in which 6 patients have been treated with 2 or less than 2 instances of DLT.
DLT for the purposes of dose-escalation or calculation of the maximum tolerated dose (MTD) defined as any medically unmanageable Grade 2 toxicity or any Grade 3 or 4 toxicity experienced during the 8 week period of combined hormone ablation, Sunitinib, and radiation therapy.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2015
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 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Paul Corn, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631527
- Sponsor's protocol ID
- 2006-0684
- Other IDs
- NCI-2010-01524
- Status last verified
- Jan 2015
- First submitted
- 27 Feb 2008
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Karlou M, Tzelepi V, Efstathiou E. Therapeutic targeting of the prostate cancer microenvironment. Nat Rev Urol. 2010 Sep;7(9):494-509. doi: 10.1038/nrurol.2010.134.
PubMed 20818327
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT00631527
- Acronym / sponsor ID
- 2006-0684
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Radiation Therapy, RT, Radiotherapy, Hormone Ablation, Sunitinib Malate, Leuprolide, Lupron
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2008
- Primary completion
- Jan 2015 (actual)
- First posted
- 7 Mar 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.
The goal of this clinical research study is to learn the safety of adding 3 different dose-levels of Sutent® (sunitinib malate) to a combination of hormone therapy and radiation in patients with prostate cancer.
Detailed description
The Study Drugs:
Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.
Luteinizing Hormone-Releasing Hormone (LHRH) Analogues like Lupron® (leuprolide) and Zoladex® (goserelin) are hormonal treatments used to help stop the body from making testosterone (male sex hormones) in the body. Prostate cancer cells need testosterone to survive.
Anti-Androgen drugs, like Casodex® (bicalutamide) also stop cell growth by blocking male hormones like testosterone.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will be assigned to a study group. The group you are assigned to and dose of sunitinib malate you receive will depend on when you join this study. Three (3) dose levels of sunitinib malate will be tested. The first group of participants will receive the lowest dose of sunitinib malate. The next group enrolled will receive a higher dose of sunitinib malate, if no intolerable side effects were seen.
Before you begin taking sunitinib, you will begin receiving hormone therapy. You will receive leuprolide or goserelin. Leuprolide is given through a needle in your muscle, and goserelin is given through a needle under the skin in the abdomen. You will receive 1 of these injections every 3 months. Which hormonal drug you are given (leuprolide or goserelin) will be assigned by your doctor and/or will depend on your insurance coverage.
You may also receive bicalutamide. This will be left up to the doctor. You will take bicalutamide by mouth once a day for 2 weeks (with or without food).
After at least 4 weeks of hormone therapy have been given, you will begin taking sunitinib malate in combination with the hormone therapy. You will take sunitinib malate once a day (either with or without food) for 16 weeks in a row.
Radiation Therapy:
After 4 weeks of combined treatment with sunitinib and hormone therapy, you will begin radiation treatments. Radiation treatments will be given once a day, 5 days a week, for about 8 weeks. Each treatment will take 20-30 minutes. This procedure will be discussed with you in more detail. You will continue taking sunitinib and hormone therapy while you are on radiation treatments.
Study Visits:
On the day you start treatment with sunitinib, you will have the following tests and procedures performed:
- You will have a physical exam, including measurements of your blood pressure and weight.
- You will be asked about any side effects you may have had since your last visit.
- Blood (about 1 teaspoon) will be drawn for routine tests.
About Day 15 of treatment with sunitinib, and on the day you begin radiation therapy (before your first treatment), you will have the following tests and procedures performed:
- You will have a physical exam, including measurements of your blood pressure and weight.
- You will be asked about any side effects you may have had since your last visit.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Every 2 weeks during radiation therapy, you will have the following tests and procedures performed:
- You will have a physical exam, including measurements of your blood pressure and weight (every 2 weeks)
- You will have blood drawn (about 2 teaspoons) for routine testing.
- You will be asked about any side effects you may have had since your last visit.
About 4 weeks after you stop radiation therapy, you will have the following test and procedures performed:
- You will have a physical exam, including measurements of your blood pressure and weight.
- Blood (about 2 teaspoons) and urine will be collected for routine tests. The blood testing will include measurement of prostatic specific antigen (PSA) and testosterone levels.
- You will be asked about any side effects you have had since your last visit.
Length of Study:
You will continue taking sunitinib malate on this study for a total of 16 weeks. Radiation treatments will last for up to 8 weeks. Hormone injections will continue for a period of 2 years. You will be taken off this study if intolerable side effects occur or the disease gets worse.
Long-Term Follow-up:
You will be followed every 6 months via telephone call and/or a review of your medical record. If contacted, you will be asked about any side effects you have had, or therapies you may have had since stopping treatment on this study. You will be followed for up to 10 years once you have taken sunitinib malate for 20 weeks.
This is an investigational study. Sunitinib malate is FDA approved and commercially available for the treatment of adults with kidney cancer.
Bicalutamide, leuprolide, and goserelin are FDA approved and commercially available for use in prostate cancer.
Up to 22 patients will be enrolled in this multicenter trial. Up to 12 will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunitinib Malate, Hormone Ablation + RT | Experimental | Drug: Leuprolide, Drug: Goserelin, Drug: Sunitinib Malate, Drug: Casodex, Radiation: Radiation Therapy (RT)Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adenocarcinoma of the prostate with the following high-risk features are eligible: clinical T2c, clinical or pathological T3 or T4 disease OR Gleason 8-10 disease OR PSA > 20ng/ml.
- Patients must have no evidence of metastatic disease by clinical and radiological staging including Chest X-ray, Bone scan and CT Scan of the Abdomen and Pelvis.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Calculated Creatinine clearance > 35cc/min, Absolute neutrophil count > 1,500/mm^3, Platelets >/= 100,000/mm^3, AST/ALT < 2.5 x upper normal limit (UNL), Total bilirubin within normal limits (WNL).
- No standard contraindications to radiation therapy including prior radiation therapy, inflammatory bowel disease, irritable bowel syndrome, or and collagen vascular disease.
Key exclusion criteria (5 listed)
- Prior VEGFR/PDGFR inhibitor or other investigational therapy.
- Inability to take oral medication
- Chronically uncontrolled hypertension, defined conventionally as consistent/repeated systolic pressures above 140 mmHg or diastolic pressures above 90 mmHg despite anti-hypertensive therapy. This may be established with home BP readings. There is no criterion related to a specific BP result required for eligibility, nor are acute BP elevations that are related to iatrogenic causes, acute pain, or other transient reversible causes considered an exclusion criteria. The intent is to exclude patients with chronically uncontrolled hypertension that might be further exacerbated by Sunitinib.
- Left Ventricular Ejection Fraction </= 40%, symptomatic congestive heart failure or symptomatic ischemic heart disease, deep venous thrombosis or pulmonary embolism in the last 12 months.
- Known human immunodeficiency virus infection, alcoholism, chronic active hepatitis or liver cirrhosis.
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 |
|---|---|---|
| LeuprolideAlso: LupronInjections given through a needle in the muscle every 3 months. | Drug | Sunitinib Malate, Hormone Ablation + RT |
| GoserelinAlso: ZoladexSubcutaneous injections given once every 3 months. | Drug | Sunitinib Malate, Hormone Ablation + RT |
| Sunitinib MalateAlso: SU011248, SutentStarting dose of 12.5 mg by mouth daily for 4 weeks | Drug | Sunitinib Malate, Hormone Ablation + RT |
| CasodexAlso: BicalutamideOnce a day by mouth for 2 weeks. | Drug | Sunitinib Malate, Hormone Ablation + RT |
| Radiation Therapy (RT)Also: RadiotherapyRadiation treatment once daily over a period of 8 weeks. | Radiation | Sunitinib Malate, Hormone Ablation + RT |
Primary outcome
Maximum Tolerated Dose (MTD) as defined by Dose Limiting Toxicity (DLT)
Time frame: 8 weeks
DLT defined as inability to complete the schedule course of radiation therapy for toxicity of any grade. If < 2 patients in initial cohort of 6 experience DLT then a subsequent dose-level cohort initiated. If 2 or more patients in a cohort experience DLT then further accrual to that cohort curtailed and no higher dose level examined. Maximum tolerated dose (MTD) for oral sunitinib in combination with radiation and hormone ablation defined as highest dose level in which 6 patients have been treated with 2 or less than 2 instances of DLT. DLT for the purposes of dose-escalation or calculation of the maximum tolerated dose (MTD) defined as any medically unmanageable Grade 2 toxicity or any Grade 3 or 4 toxicity experienced during the 8 week period of combined hormone ablation, Sunitinib, and radiation therapy.
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 29 Jan 2015.
- Derived from this study: PubMed 20818327Karlou M, Tzelepi V, Efstathiou E. Therapeutic targeting of the prostate cancer microenvironment. Nat Rev Urol. 2010 Sep;7(9):494-509. doi: 10.1038/nrurol.2010.134.
- University of Texas 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.
Paul Corn, MD, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Leuprolide, Goserelin and Sunitinib Malate in people with Prostate Cancer, run by M.D. Anderson Cancer Center 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 7 inclusion and 5 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 29 Jan 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum Tolerated Dose (MTD) as defined by Dose Limiting Toxicity (DLT) (time frame: 8 weeks). 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 NCT00631527, 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 29 Jan 2015.