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Cabazitaxel and Radiation For Patients With Pathologically Determined Stage 3 Prostate Cancer and/or Patients With PSA Elevation (>0.1- < 2.0 ng/mL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Brown University
Sponsor:
Information provided by (Responsible Party):
Dr Anthony Mega, Brown University
ClinicalTrials.gov Identifier:
NCT01650285
First received: July 24, 2012
Last updated: April 4, 2013
Last verified: January 2013

July 24, 2012
April 4, 2013
January 2013
January 2014   (final data collection date for primary outcome measure)
To determine the maximum tolerated dose of cabazitaxel with concurrent adjuvant radiation [ Time Frame: 2 mos ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01650285 on ClinicalTrials.gov Archive Site
To assess the toxicity associated with cabazitaxel and adjuvant radiation [ Time Frame: 2 mos ] [ Designated as safety issue: Yes ]
Same as current
To determine the time to progression and overall survival for patients-Following Radical Prostatectomy and were treated with cabazitaxel. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To determine the time to progression and overall survival for patients-Following Radical Prostatectomy and were treated with cabazitaxal. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
 
Cabazitaxel and Radiation For Patients With Pathologically Determined Stage 3 Prostate Cancer and/or Patients With PSA Elevation (>0.1- < 2.0 ng/mL)
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).

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: Cabazitaxel

Dose Level Day 1, 22, 43

  1. 5.0 mg/m2
  2. 10.0 mg/m2
  3. 15.0 mg/m2
  4. 20.0 mg/m2
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.
Intervention: Drug: Cabazitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
January 2016
January 2014   (final data collection date for primary outcome measure)

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;
Male
18 Years and older
No
Contact: Kayla Rosati 401-863-3000 kayla_rosati@brown.edu
United States
 
NCT01650285
BrUOG 246
Yes
Dr Anthony Mega, Brown University
Brown University
Not Provided
Study Chair: Howard Safran, MD Brown University Oncology Research Group
Principal Investigator: anthony mega, md Lifespan
Brown University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP