Prostate CancerPhase 1/2NCT00879619
Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer Patients
A Phase 1/2 study testing sunitinib malate, docetaxel and prednisone in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by John P. Fruehauf at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Adenocarcinoma of the Prostate, Recurrent Prostate Cancer
- What is being tested?
- sunitinib malate, docetaxel and prednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Nov 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects must have a histological diagnosis of adenocarcinoma of the prostate
- Age ≥ 18
- Subjects must have metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy by one or more of the following (despite androgen deprivation and anti-androgen withdrawal when applicable) check all that apply.
- Subjects may have received prior surgery. However, at least 21 days must have elapsed since completion of surgery and Subject must have recovered from all side effects.
- Subjects must have adequate hepatic function as defined by:
- a serum bilirubin ≤1.5 x the institutional upper limit of normal (IULN),
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- Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) ≤2.5 x the institutional upper limit of normal obtained within 14 days prior to start of therapy
- Subjects must have 2 pre-study PSA > 2ng/ml at least 1 week apart within 28 days prior to start of therapy
- Subjects must have been surgically or medically castrated. If method of castration is luteinizing hormone-releasing hormone (LHRH) agonist (leuprolide or goserelin), then the Subject should be willing to continue the use of LHRH agonists. Castration using LHRH agonist should not be interrupted and subjects who have stopped treatment should be willing to restart.
- Subjects must not take vitamins, herbs, or micronutrient supplement within 28 days prior to start of therapy.
- Prior external beam radiation therapy (to less than 30% of the bone marrow only) is allowed. This includes prior use of samarium, but subjects can not have received prior strontium. At least 28 days must have elapsed since the completion of radiation therapy and the Subject must have recovered from side effects. Soft tissue disease which has been radiated in the prior 2 months is not assessable as measurable disease.
- Subjects with a history of myocardial infarction are not eligible. Subjects must have a baseline EKG to rule out underlying cardiac disease within 42 days prior to registration. Subjects with a history of cardiac disease, specifically congestive heart failure (CHF) are ineligible unless their disease is well-controlled. Subjects with history of cardiovascular accident (CVA) or atrial fibrillation are ineligible.
- Subjects with a history of brain metastases or who currently have treated or untreated brain metastases are not eligible. Subjects with clinical evidence of brain metastases must have a brain CT or MRI negative for metastatic disease within 56 days prior to registration.
- Liver function tests should be evaluated prior to each treatment.
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Subjects must have an adequate renal function as defined by:
- a serum creatinine ≤1.5 x the institutional upper limit of normal obtained within 14 days prior to start of therapy and a urine protein: creatinine (UPC) ratio of ≤ 1.0.
- Subjects must have the following hematological criteria (minimal values):
- Absolute neutrophil count ≥ 1,500/mm³
- Hemoglobin of ≥ 8.0gm/dL,
- White blood cell count ≥ 2500,
- Platelets ≥ 75,000/mm³
- Subjects must be able to take oral medications
Who cannot join
- Subjects must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to start of therapy and must have recovered from toxicities of prior therapy to grade 1 or less with the exception of alopecia.
- Subjects may not have ongoing problems with bowel obstruction or short bowel syndrome characterized by grade 2 or greater diarrhea or malabsorptive disorders.
- Men of child bearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- Subjects with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 will be excluded
- Subjects should not have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up or compliance with the study protocol.
- Subjects should not have any medical life-threatening complications of their malignancies
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- Subjects should not have a known severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, active uncontrolled infection, or HIV).
- Subjects should not have current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
- Baseline blood pressure of < or equal to 150/100 mmHg. Subjects with a blood pressure reading above this level should be initiated on anti-hypertensive therapy and may be considered for protocol treatment when their blood pressure is adequately controlled.
- Subjects with New York Heart Association (NYHA) Grade II or greater congestive heart failure are not eligible. Subjects must have a baseline multiple gated acquisition scan (MUGA) or Echocardiogram with a calculated ejection fraction > or equal to 50%.
- Subjects with clinically significant peripheral vascular disease are not eligible.
- Subjects with evidence of bleeding diathesis or coagulopathy are not eligible.
- Subjects with central nervous system or brain metastases are not eligible.
- Subjects who had major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study are not eligible.
- Subjects with minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0 are not eligible.
- Subjects with history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess are not eligible.
- Subjects with serious, non-healing wound, ulcer, or bone fracture are not eligible.
- Subjects who are diagnosed of any other malignancy except non-melanomatous skin cancer in the past 5 years are not eligible.
- Subjects receiving anticoagulation therapy (e.g. Coumadin) prior to registration are not eligible. Subjects are permitted to have prior Coumadin for prophylaxis against agents that might produce blood clots. Subjects with low dose Aspirin (86mg) are acceptable.
- Subjects with active thrombophlebitis or hypercoagulability are not eligible. Subjects with known history of pulmonary embolus are not eligible.
- All Subjects must be informed and must sign and give written informed consent in accordance with institutional and federal guidelines. Subjects who are unable to comply with study and/or follow-up procedures are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chao Comprehensive Cancer Center
Orange, California, 92868
About this study
Official title: A Pilot Phase I/II Study to Evaluate the Effects of Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer Patients With Biochemical Relapse
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel and prednisone together with sunitinib malate may kill more tumor cells.
PURPOSE: This pilot phase I/II trial studies the side effects and best way to give docetaxel and prednisone together with sunitinib malate and to see how well it works in treating patients with prostate cancer that progressed after hormone therapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the response by prostate specific antigen (PSA) of docetaxel/prednisone plus sunitinib (sunitinib malate) in chemotherapy-naive, hormone refractory prostate cancer subjects with biochemical relapse.
SECONDARY OBJECTIVES:
- To determine the objective response rate (ORR) and duration of response (DR) in subjects with measurable disease.
II. To determine overall survival (OS) and time to progression (TTP). III. To evaluate the safety and tolerability of sunitinib in combination with docetaxel and prednisone.
OUTLINE:
Patients receive docetaxel intravenously (IV) over 60 minutes on day 1, prednisone orally (PO) twice daily (BID) on days 1-21, and sunitinib malate PO once daily (QD) on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 3 years.
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer
- Being tested
- sunitinib malate, docetaxel, prednisone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinib malateDrug
Also called SU11248, sunitinib
Given PO
docetaxelDrug
Also called TXT
Given IV
prednisoneDrug
Also called Delta(1)-Cortisone, deltacortisone, deltadehydrocortisone, metacortandracin
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy and enzyme inhibitor | Experimental | Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: sunitinib malate; Drug: docetaxel; Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate Specific Antigen (PSA) Response Rate
Defined by >= 30% decline in PSA from baseline for at least 3 months during study entry. Response rates will be expressed with two-sided exact binomial confidence intervals. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. Associations between PSA response and tumor response will also be examined by Fisher's exact test.
Measured: Baseline, every 3 weeks, at study termination, and then for 3 years
Secondary outcomes (5)
Rates of Tumor Response (ORR)
Response rates will be expressed with two-sided exact binomial confidence intervals. The difference of response rates between different pre-treatment pathological stages or Gleason scores will also be examined by Fisher's exact test. Associations between PSA response and tumor response will also be examined by Fisher's exact test.
Measured: Every 2 months
Duration of Response (DR)
Response rates will be expressed with two-sided exact binomial confidence intervals.
Measured: Up to 3 years
Time to Progression (TTP) by PSA Response and Disease Response
Defined as an absolute increase in PSA of at least 2 ng/ml. For subjects with measurable disease, Response Evaluation Criteria In Solid Tumors (RECIST) criteria will be used. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. Associations between PSA response and tumor response will also be examined by Fisher's exact test.
Measured: Baseline, every 3 weeks, at study termination, and then for 3 years
Survival
Quantitative Kaplan-Meyer estimates of progression-free survival and overall survival will be determined.
Measured: At 2 and 3 years
Qualitative and Quantitative Toxicity
Severity will be categorized by toxicity grade according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Categorical analysis of toxicities will be performed.
Measured: Every 3 weeks and at study termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2011
- Study completionNov 2011
Why it stopped: Terminated due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- John P. Fruehauf
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor-investigator, John P. Fruehauf, University of California, Irvine
- Investigators
- John P Fruehauf, MD, PhD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879619
- Sponsor's protocol ID
- UCI 07-64
- Other IDs
- 2008-6187, NCI-2010-00216
- Status last verified
- Apr 2013
- First submitted
- 8 Apr 2009
- Last updated
- 1 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase I/II Study to Evaluate the Effects of Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer Patients With Biochemical Relapse
- ClinicalTrials.gov ID
- NCT00879619
- Acronym / sponsor ID
- UCI 07-64
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow accrual.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- John P. FruehaufUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jul 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 10 Apr 2009 (estimated)
- Results
- Posted 6 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel and prednisone together with sunitinib malate may kill more tumor cells.
PURPOSE: This pilot phase I/II trial studies the side effects and best way to give docetaxel and prednisone together with sunitinib malate and to see how well it works in treating patients with prostate cancer that progressed after hormone therapy.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the response by prostate specific antigen (PSA) of docetaxel/prednisone plus sunitinib (sunitinib malate) in chemotherapy-naive, hormone refractory prostate cancer subjects with biochemical relapse.
SECONDARY OBJECTIVES:
- To determine the objective response rate (ORR) and duration of response (DR) in subjects with measurable disease.
II. To determine overall survival (OS) and time to progression (TTP). III. To evaluate the safety and tolerability of sunitinib in combination with docetaxel and prednisone.
OUTLINE:
Patients receive docetaxel intravenously (IV) over 60 minutes on day 1, prednisone orally (PO) twice daily (BID) on days 1-21, and sunitinib malate PO once daily (QD) on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy and enzyme inhibitor | Experimental | Drug: sunitinib malate, Drug: docetaxel, Drug: prednisonePatients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Subjects must have a histological diagnosis of adenocarcinoma of the prostate
- Age ≥ 18
- Subjects must have metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy by one or more of the following (despite androgen deprivation and anti-androgen withdrawal when applicable) check all that apply.
- Subjects may have received prior surgery. However, at least 21 days must have elapsed since completion of surgery and Subject must have recovered from all side effects.
- Subjects must have adequate hepatic function as defined by:
Key exclusion criteria (21 listed)
- Subjects must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to start of therapy and must have recovered from toxicities of prior therapy to grade 1 or less with the exception of alopecia.
- Subjects may not have ongoing problems with bowel obstruction or short bowel syndrome characterized by grade 2 or greater diarrhea or malabsorptive disorders.
- Men of child bearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- Subjects with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 will be excluded
- Subjects should not have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up or compliance with the study protocol.
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 |
|---|---|---|
| sunitinib malateAlso: SU11248, sunitinibGiven PO | Drug | Chemotherapy and enzyme inhibitor |
| docetaxelAlso: TXTGiven IV | Drug | Chemotherapy and enzyme inhibitor |
| prednisoneAlso: Delta(1)-Cortisone, deltacortisone, deltadehydrocortisone, metacortandracinGiven PO | Drug | Chemotherapy and enzyme inhibitor |
Primary outcome
Prostate Specific Antigen (PSA) Response Rate
Time frame: Baseline, every 3 weeks, at study termination, and then for 3 years
Defined by >= 30% decline in PSA from baseline for at least 3 months during study entry. Response rates will be expressed with two-sided exact binomial confidence intervals. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. Associations between PSA response and tumor response will also be examined by Fisher's exact test.
5 secondary outcomes
Rates of Tumor Response (ORR)
Time frame: Every 2 months
Duration of Response (DR)
Time frame: Up to 3 years
Time to Progression (TTP) by PSA Response and Disease Response
Time frame: Baseline, every 3 weeks, at study termination, and then for 3 years
Survival
Time frame: At 2 and 3 years
Qualitative and Quantitative Toxicity
Time frame: Every 3 weeks and at study termination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- (UCi Clinical Trials webpageLink 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.
John P Fruehauf, MD, PhD principal investigator
Chao Family Comprehensive 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 1/2 study testing sunitinib malate, docetaxel and prednisone in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by John P. Fruehauf 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 23 inclusion and 21 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 1 Feb 2017. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 6 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Prostate Specific Antigen (PSA) Response Rate (time frame: Baseline, every 3 weeks, at study termination, and then for 3 years). 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 1 Feb 2017.