- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01650285
Cabazitaxel and Radiation For Patients With Prostate Cancer
February 23, 2022 updated by: Brown University
Cabazitaxel and Radiation For Patients With Pathologically Determined Stage 3 Prostate Cancer and/or Patients With PSA Elevation (>0.1- < 2.0 ng/mL) Following Radical Prostatectomy
There is a high relapse rate for patients who have undergone prostatectomy and have pathologic extracapsular prostate extension, positive surgical margins or seminal vesicle involvement (pathologic stage 3 disease).
While adjuvant radiation improves progression-free and overall survival, approximately half of these patients will develop recurrence.
Similarly, radiation therapy has become the standard salvage therapy for patients with rising PSA >0.1 - < 2.0 ng/mL.
In common solid tumors such as NSCLC, head and neck cancer and upper gastrointestinal cancers, the addition of chemotherapy to radiation improves survival.
It is hypothesized that the addition of radiosensitizing chemotherapy to standard adjuvant radiation will improve survival in patients with stage 3 prostate cancer after prostatectomy and patients with rising PSA < 2.0 ng.mL without detectable disease.
Taxanes are powerful radiation enhancers since they synchronize tumor cells in G2/M the most radiosensitive phase of the cell cycle.17,18
Cabazitaxel is the most active taxane in the treatment of prostate cancer.
Therefore, we propose a phase I study establishing the optimal dose of cabazitaxel with adjuvant radiation for stage 3 prostate cancer after prostatectomy (PSA undetectable - < 2.0 ng/mL).
and for patients with persistent or rising PSA post prostatectomy (PSA >0.1 - < 2.0 ng/mL).
Study Overview
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 06902
- Miriam Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Conditions for Patient Eligibility
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
Radical prostatectomy for adenocarcinoma of the prostate with at least one of the following:
- Extracapsular tumor extension,
- Positive surgical margins,
- Seminal vesicle invasion
- Regional lymph node positive (N1)
- Post-prostatectomy PSA of > 0.1 - < 2.0 ng/mL at least 6 weeks after prostatectomy and within 30 days of registration in a patient with T2 or T3 disease at prostatectomy.
- No distant metastases.
- No prior pelvic or prostate radiation or chemotherapy for prostate cancer.
- ECOG performance status 0-1.
- Age>18.
- Required entry laboratory parameters within 14 days of study entry: Granulocytes ≥ 1500 cells/mm3; platelet count ≥100,000 cells/mm3, Creatinine ≤ 1.5X upper limit of normal (if creatinine clearance 1.0-1.5x ULN, creatinine clearance will be calculated according to Chronic Kidney Disease Epidemiology Group formula and patients with creatinine clearance < 60 ml/min should be excluded),19 .Hgb > 9.0 g/dl, total bilirubin ≤ 1x ULN, and AST or ALT ≤ 2.5 x ULN.
- Life expectancy of at least 1 year.
- Must not have uncontrolled severe, intercurrent illness.
- No concurrent anticancer therapy.
- Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- Signed study-specific consent form prior to study entry.
- Conditions for Patient Ineligibility
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Evidence of distant metastases (M1). Equivocal bone scans are allowed if plain films are negative for metastasis.
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the oral cavity or bladder are permissible).
- History of severe hypersensitivity (> grade 3) reaction to Cabazitaxel or other drugs formulated with polysorbate 80.
- History of severe hypersensitivity (> grade 3) to docetaxel.
- Any uncontrolled severe, intercurrent illness (including uncontrolled diabetes)
- At least 4 weeks since any major surgery.
- Patients on concurrent anticancer therapy.
- PSA > 2ng/ml
- Concurrent or planned treatment with strong inhibitors or inducers of cytochrome p450 3A4/5 (a one-week wash out period is necessary for patients who are already on these treatments (see appendix H and I)
- Androgen deprivation therapy started prior to prostatectomy for > 6 months duration;
- Neoadjuvant chemotherapy prior to prostatectomy;
- Prior cryosurgery or brachytherapy of the prostate; prostatectomy should be the primary treatment and not a salvage procedure;
- Prior pelvic radiotherapy;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cabazitaxel and radiation
Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.
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Dose Level Day 1, 22, 43
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose of Cabazitaxel With Concurrent Adjuvant Radiation
Time Frame: 2 mos
|
The MTD was not determined secondary to the study closing early.
That being said the numbers provided below show that 4 patients were treated on study to aide in the investigation of the MTD.
Only 1 dose was fully evaluated which was 5mg/m2
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2 mos
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Experiencing a Toxicity Associated With Cabazitaxel and Adjuvant Radiation Following Prostatectomy for Patients With Stage 3 Prostate Cancer and for Patients With a PSA Elevation Post-Prostatectomy.
Time Frame: During study treatment (approximately 8 weeks) through 30 days post treatment, approximately 12 weeks.
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Assess toxicity using CTCAE version 4.0.
Number of patients who experienced a toxicity on the study.
Not all toxicities are related to study treatment.
Of note, there were no serious adverse events on this trial.
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During study treatment (approximately 8 weeks) through 30 days post treatment, approximately 12 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: anthony mega, md, Lifespan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
July 24, 2012
First Submitted That Met QC Criteria
July 24, 2012
First Posted (Estimate)
July 26, 2012
Study Record Updates
Last Update Posted (Actual)
March 4, 2022
Last Update Submitted That Met QC Criteria
February 23, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BrUOG 246
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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