Castrate-resistant Metastatic Prostate CancerPhase 2NCT01750866
Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer
A Phase 2 study testing Cabazitaxel, Prednisone and Granulocyte colony-stimulating factor (G-CSF) in people with Castrate-resistant Metastatic Prostate Cancer, run by Case Comprehensive Cancer Center.
Trial summary
Cabazitaxel is already approved by the Food and Drug Administration (FDA) for use in patients with advanced prostrate cancer, following docetaxel therapy. The purpose of this study is to better understand the response and toxicity of cabazitaxel of elderly men (age 75 years and older) with advanced prostate cancer who… Read more about this study
- Who is it for?
- Ages 75 years and older, men only
- Conditions the study is for
- Castrate-resistant Metastatic Prostate Cancer
- What is being tested?
- Cabazitaxel, Prednisone and Granulocyte colony-stimulating factor (G-CSF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Oct 2013
- 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 75 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically proven, castrate-resistant metastatic prostate cancer without neuroendocrine differentiation or small cell histology
- Age ≥ 75 years of age
- Progressive disease despite:
- Previous therapy with docetaxel
- Progressive disease for study enrollment is defined by either:
- PSA criteria according to the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria with a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination and a PSA at the screening visit of ≥ 2 ng/ml
Show all 27Show fewer
- Radiographic progression in soft tissue according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria
- Appearance of two or more lesions on a bone
- Previous treatment with abiraterone acetate or enzalutamide is allowed, but last dose must be at least 14 days prior to enrollment in this trial.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Ongoing androgen deprivation with a serum testosterone < 50 ng/dL
- A score of 8-14 on the Mini Nutritional Assessment (MNA) (normal nutritional status or at risk of malnutrition). MNA in Appendix 4 and available at www.mna-elderly.com.
- Patients must have the following laboratory values:
- Hematologic:
- Absolute Neutrophil Count (ANC) >/=1.5x109/L
- Hemoglobin (Hgb) >/=9 g/dl
- Platelets (plt) >/=100x109/L
- Biochemistry :
- Potassium within normal limits or correctable with supplements
- Total calcium (corrected for serum albumin) and phosphorus within normal limits Liver and Kidney Functions
- AST (aspartate aminotransferase/glutamic oxaloacetic transaminase/GOT)and ALT (alanine aminotransferase/glutamic pyruvic transaminase/GPT) ≤ 1.5 x Upper Limit of Normal (ULN)
- Serum bilirubin </= 1 x ULN
- Serum creatinine </= 1.5 x ULN. If creatinine is 1.0 to 1.5 x ULN, creatinine clearance will be calculated according to the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula and only patients with a creatinine clearance > 60 mL/min will be included.
- Life expectancy of ≥ 6 months
- No concomitant anticancer or investigational drug or participation in an investigational trial within 30 days of starting treatment with cabazitaxel. Treatment with nitrosoureas, mitomycin, or monoclonal antibodies, such as trastuzumab, must be ≥ 6 weeks
- Male participants with partners who are of child bearing potential must agree to use double barrier method of birth control 28 days prior to study entry, during the study and for 28 days following the last dose of cabazitaxel OR have history of a vasectomy.
- Signed informed consent indicating an understanding of the purpose of the study and the necessary procedures and willingness to participate
Who cannot join
- History of severe hypersensitivity reaction (≥grade 3) to docetaxel and polysorbate 80 containing drugs
- Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
- Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments)
- Previous treatment with cabazitaxel
- Patients with Central Nervous System (CNS) metastasis. Patients without clinical signs or symptoms of CNS involvement are not required to have a CT/MRI of the brain
- Clinically significant cardiac disease within 6 months, including myocardial infarction, New York Heart Association (NYHA) Class III or IV heart disease, or left ventricular ejection fraction of < 50% at baseline for patients with a history of congestive heart failure.
Show all 11Show fewer
- History of another malignancy in the previous 5 years with the exception of curatively treated non-melanomatous skin cancer.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness due to potential pharmacokinetic interactions of therapy with cabazitaxel.
- Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this trial.
- Unresolved toxicities from previous chemotherapy which has not resolved to ≤ grade 1 by CTCAE Version 4.02 criteria with the exception of alopecia or grade 2 peripheral neuropathy.
- Major surgery ≤ 2 weeks prior to the start of the study or who have not recovered from a previous surgery. (Placement of a venous access device within 2 weeks is permitted)
About this study
Official title: Efficacy and Toxicity of Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer With Progression After Treatment With Docetaxel
Cabazitaxel is already approved by the Food and Drug Administration (FDA) for use in patients with advanced prostrate cancer, following docetaxel therapy. The purpose of this study is to better understand the response and toxicity of cabazitaxel of elderly men (age 75 years and older) with advanced prostate cancer who have progressed during or after treatment with docetaxel. All patients on this study will receive cabazitaxel by intravenous (through a vein) infusion plus prednisone by mouth twice daily, and following the chemotherapy infusions, an injection of a granulocyte colony-stimulating factor (G-CSF). G-CSF will help the body produce more white blood cells, which should help decrease the risk of getting an infection while being treated with cabazitaxel.
Read the detailed description
This is a single arm, open label, phase II trial of cabazitaxel every 3 weeks in patients who are ≥ 75 years of age with castration-resistant, metastatic prostate cancer who have progressed during or after docetaxel.
Primary objective:
-The primary objective is to determine the efficacy of cabazitaxel in men 75 years of age or older with castration-resistant, metastatic prostate cancer who have progressed during of following treatment with docetaxel.
Secondary objectives:
- To characterize the safety and tolerability of cabazitaxel in patients ≥ 75 years of age
- To determine the PSA response
- To determine the effect of cabazitaxel on functional status using geriatric assessments
Exploratory objectives:
- Determine the effect of therapy with cabazitaxel on the number of circulating tumor cells (CTC)
- To measure the effects of cabazitaxel on apoptosis in CTCs from patients ≥ 75 years of age using H2AX and M30 as biomarkers.
- To determine the relationship between geriatric-focused assessment of comorbidity and functional ability and toxicity and response.
Patients will receive cabazitaxel 25 mg/m2 every 3 weeks with 10 mg prednisone daily until progression, intolerance of therapy, or withdrawal of consent. Patients will receive granulocyte colony stimulating factor (Neulasta 6 mg sc) with each cycle, starting with the first cycle, to minimize the risk of complications from neutropenia. Patients will be followed for 28 days after discontinuation of therapy or death, whichever occurs first. Patients with serious adverse events at the time of removal from the trial will be followed until the toxicities resolve or are deemed irreversible by the treating physician.
- Being tested
- Cabazitaxel, Prednisone, Granulocyte colony-stimulating factor (G-CSF)
- Keywords
- Prostrate Cancer, Castrate-resistant metastatic prostate cancer, Cabazitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
Also called taxoid XRP6258, Jevtana, RPR-116258A, XRP6258
Cabazitaxel 25 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
PrednisoneDrug
Prednisone 10 mg on Day 1 of the first cycle and continue taking 10 mg po daily for the entire cycle.
Granulocyte colony-stimulating factor (G-CSF)Drug
Granulocyte colony stimulating factor (Neulasta 6 mg sc) with each cycle, starting with the first cycle, to minimize the risk of complications from neutropenia.
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel | Experimental | Cabazitaxel 25 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. Treatment will continue until disease progression, intolerable side effects, or a maximum of 10 cycles of therapy. Receives: Drug: Cabazitaxel; Drug: Prednisone; Drug: Granulocyte colony-stimulating factor (G-CSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients progression-free survival after completion of treatment.
Treatment will continue until disease progression, intolerable side effects, or a maximum of 10 cycles of therapy. Progression-free survival defined as PSA progression, tumor progression in patients with measurable disease, or death.
Measured: at end of treatment (up to 30 weeks)
Secondary outcomes (3)
Number of patients that experience treatment-emergent adverse events
The assessment of safety will be based on the frequency and severity of adverse events. The incidence of treatment-emergent adverse events will be summarized by organ system, severity based on CTCAE (Common Terminology Criteria for Adverse Events) version 4.02, and relation to study drug by dose cohort. Adverse events assessed after each treatment cycle.
Measured: at end of each treatment cycle (up to 30 weeks)
Number of patients with a prostate-specific antigen (PSA) response
PSA response defined as a 50% or more reduction in serum PSA concentration in patients with a serum PSA concentration of 20 μg/L or more at baseline and confirmed with a repeat PSA measurement after at least 3 weeks.
Measured: at end of each treatment cycle (up to 30 weeks)
Change in geriatric assessments from baseline to end of therapy
Geriatric assessment to determine the relationship between functional ability or comorbidity and treatment response or toxicity. Patients will be have a geriatric assessment which will included a range of assessments, such as the Mini Mental Status Exam, Get Up and Go test, and the Geriatric Depression Scale, at baseline and after every 2 cycles of therapy.
Measured: every 2 cycles of therapy (6 weeks) up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: No accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castrate-resistant Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive 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
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dale Shepard, Md, PhD, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750866
- Sponsor's protocol ID
- CASE3811
- Other IDs
- NCI-2012-02993
- Status last verified
- Oct 2013
- First submitted
- 13 Dec 2012
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Toxicity of Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer With Progression After Treatment With Docetaxel
- ClinicalTrials.gov ID
- NCT01750866
- Acronym / sponsor ID
- CASE3811
- Keywords
- Prostrate Cancer, Castrate-resistant metastatic prostate cancer, Cabazitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 Dec 2012 (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.
Cabazitaxel is already approved by the Food and Drug Administration (FDA) for use in patients with advanced prostrate cancer, following docetaxel therapy. The purpose of this study is to better understand the response and toxicity of cabazitaxel of elderly men (age 75 years and older) with advanced prostate cancer who have progressed during or after treatment with docetaxel. All patients on this study will receive cabazitaxel by intravenous (through a vein) infusion plus prednisone by mouth twice daily, and following the chemotherapy infusions, an injection of a granulocyte colony-stimulating factor (G-CSF). G-CSF will help the body produce more white blood cells, which should help decrease the risk of getting an infection while being treated with cabazitaxel.
Detailed description
This is a single arm, open label, phase II trial of cabazitaxel every 3 weeks in patients who are ≥ 75 years of age with castration-resistant, metastatic prostate cancer who have progressed during or after docetaxel.
Primary objective:
-The primary objective is to determine the efficacy of cabazitaxel in men 75 years of age or older with castration-resistant, metastatic prostate cancer who have progressed during of following treatment with docetaxel.
Secondary objectives:
- To characterize the safety and tolerability of cabazitaxel in patients ≥ 75 years of age
- To determine the PSA response
- To determine the effect of cabazitaxel on functional status using geriatric assessments
Exploratory objectives:
- Determine the effect of therapy with cabazitaxel on the number of circulating tumor cells (CTC)
- To measure the effects of cabazitaxel on apoptosis in CTCs from patients ≥ 75 years of age using H2AX and M30 as biomarkers.
- To determine the relationship between geriatric-focused assessment of comorbidity and functional ability and toxicity and response.
Patients will receive cabazitaxel 25 mg/m2 every 3 weeks with 10 mg prednisone daily until progression, intolerance of therapy, or withdrawal of consent. Patients will receive granulocyte colony stimulating factor (Neulasta 6 mg sc) with each cycle, starting with the first cycle, to minimize the risk of complications from neutropenia. Patients will be followed for 28 days after discontinuation of therapy or death, whichever occurs first. Patients with serious adverse events at the time of removal from the trial will be followed until the toxicities resolve or are deemed irreversible by the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel | Experimental | Drug: Cabazitaxel, Drug: Prednisone, Drug: Granulocyte colony-stimulating factor (G-CSF)Cabazitaxel 25 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. Treatment will continue until disease progression, intolerable side effects, or a maximum of 10 cycles of therapy. |
Who may qualify
- Ages
- 75 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (27 listed)
- Histologically proven, castrate-resistant metastatic prostate cancer without neuroendocrine differentiation or small cell histology
- Age ≥ 75 years of age
- Progressive disease despite:
- Previous therapy with docetaxel
- Progressive disease for study enrollment is defined by either:
Key exclusion criteria (11 listed)
- History of severe hypersensitivity reaction (≥grade 3) to docetaxel and polysorbate 80 containing drugs
- Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
- Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments)
- Previous treatment with cabazitaxel
- Patients with Central Nervous System (CNS) metastasis. Patients without clinical signs or symptoms of CNS involvement are not required to have a CT/MRI of the brain
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 |
|---|---|---|
| CabazitaxelAlso: taxoid XRP6258, Jevtana, RPR-116258A, XRP6258Cabazitaxel 25 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. | Drug | Cabazitaxel |
| PrednisonePrednisone 10 mg on Day 1 of the first cycle and continue taking 10 mg po daily for the entire cycle. | Drug | Cabazitaxel |
| Granulocyte colony-stimulating factor (G-CSF)Granulocyte colony stimulating factor (Neulasta 6 mg sc) with each cycle, starting with the first cycle, to minimize the risk of complications from neutropenia. | Drug | Cabazitaxel |
Primary outcome
Number of patients progression-free survival after completion of treatment.
Time frame: at end of treatment (up to 30 weeks)
Treatment will continue until disease progression, intolerable side effects, or a maximum of 10 cycles of therapy. Progression-free survival defined as PSA progression, tumor progression in patients with measurable disease, or death.
3 secondary outcomes
Number of patients that experience treatment-emergent adverse events
Time frame: at end of each treatment cycle (up to 30 weeks)
Number of patients with a prostate-specific antigen (PSA) response
Time frame: at end of each treatment cycle (up to 30 weeks)
Change in geriatric assessments from baseline to end of therapy
Time frame: every 2 cycles of therapy (6 weeks) up to 30 weeks
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 16 Oct 2013.
Related trials for Castrate-resistant Metastatic Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Metastatic Prostate Cancer
Active, not recruitingPhase 3
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
RecruitingPhase 3
A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 2
Dapagliflozin Combined With Next-generation Hormonal Agent (NHA) Versus Single NHA in Participants With Metastatic Castrate-resistant Prostate Cancer
Prostate Cancer, Metastatic Prostate Cancer
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.
Dale Shepard, Md, PhD principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabazitaxel, Prednisone and Granulocyte colony-stimulating factor (G-CSF) in people with Castrate-resistant Metastatic Prostate Cancer, run by Case Comprehensive 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 27 inclusion and 11 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 16 Oct 2013. 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?
Number of patients progression-free survival after completion of treatment. (time frame: at end of treatment (up to 30 weeks)). 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 16 Oct 2013.