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
  Purpose

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).


Condition Intervention Phase
Prostate Cancer
Drug: Cabazitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • To determine the maximum tolerated dose of cabazitaxel with concurrent adjuvant radiation [ Time Frame: 2 mos ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the toxicity associated with cabazitaxel and adjuvant radiation [ Time Frame: 2 mos ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650285

Contacts
Contact: Kayla Rosati 401-863-3000 kayla_rosati@brown.edu

Locations
United States, Rhode Island
Miriam Hospital Recruiting
Providence, Rhode Island, United States, 06902
Contact: kayla rosati    401-863-3000    kayla_Rosati@brown.edu   
Principal Investigator: anthony mega, md         
Sub-Investigator: angela Taber, md         
Sub-Investigator: jaroslaw hepel, md         
Sponsors and Collaborators
Brown University
Investigators
Study Chair: Howard Safran, MD Brown University Oncology Research Group
Principal Investigator: anthony mega, md Lifespan
  More Information

No publications provided

Responsible Party: Dr Anthony Mega, Priniciple Investigator, Brown University
ClinicalTrials.gov Identifier: NCT01650285     History of Changes
Other Study ID Numbers: BrUOG 246
Study First Received: July 24, 2012
Last Updated: April 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brown University:
Prostate Cancer
Radical prostatectomy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014