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Radiation Therapy and Ixabepilone in Treating Patients With High-Risk Stage III Prostate Cancer After Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01079793
Recruitment Status : Withdrawn (Overlapping study, PI preferred to enroll in alternate trial.)
First Posted : March 3, 2010
Last Update Posted : August 20, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE March 2, 2010
First Posted Date  ICMJE March 3, 2010
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE May 26, 2010
Actual Primary Completion Date October 17, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • Dose-limiting toxicity (phase I) [ Time Frame: 3 years ]
    Dose-limiting toxicity (phase I)
  • Maximum-tolerated dose (phase I) [ Time Frame: 3 years ]
    Maximum-tolerated dose (phase I)
  • Freedom from progression for 3 years (phase II) [ Time Frame: 3 years ]
    Freedom from progression for 3 years (phase II)
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
  • Dose-limiting toxicity (phase I)
  • Maximum-tolerated dose (phase I)
  • Freedom from progression for 3 years (phase II)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • Time to biochemical, local and distant failure (phase II) [ Time Frame: 3 years ]
    Time to biochemical, local and distant failure (phase II)
  • Disease-specific survival (phase II) [ Time Frame: 3 years ]
    Disease-specific survival (phase II)
  • Overall survival rate (phase II) [ Time Frame: 3 years ]
    Overall survival rate (phase II)
  • Adverse events as assessed by NCI CTCAE v. 4.0 [ Time Frame: 3 years ]
    Adverse events as assessed by NCI CTCAE v. 4.0
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
  • Time to biochemical, local and distant failure (phase II)
  • Disease-specific survival (phase II)
  • Overall survival rate (phase II)
  • Adverse events as assessed by NCI CTCAE v. 4.0
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy and Ixabepilone in Treating Patients With High-Risk Stage III Prostate Cancer After Surgery
Official Title  ICMJE A Phase I/II Study of Adjuvant Prostate Irradiation and Ixabepilone For High Risk Prostate Cancer Post-Prostatectomy
Brief Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Ixabepilone may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy with chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone when given together with radiation therapy to see how well it works in treating patients with high-risk stage III prostate cancer after surgery.

Detailed Description

OBJECTIVES:

Primary

  • To determine the maximum-tolerated dose and dose-limiting toxicity of ixabepilone in combination with concurrent intensity-modulated radiation therapy in patients with high-risk prostate cancer after prostatectomy. (Phase I)
  • To determine the toxicity profile of this regimen in these patients. (Phase I)

Secondary

  • To assess freedom from progression in patients treated with this regimen. (Phase II)
  • To assess biochemical failure, local failure, and distant failure in patients treated with this regimen. (Phase II)
  • To assess disease-specific survival and overall survival of patients treated with this regimen. (Phase II)
  • To evaluate acute and late toxicity of this regimen in these patients.

OUTLINE: This is a phase I, dose-escalation study of ixabepilone followed by a phase II study.

Patients undergo adjuvant intensity-modulated radiation therapy once daily, 5 days a week, for 7-9 weeks. Patients also receive concurrent ixabepilone IV over 1 hour on days 1 and 8. Treatment with ixabepilone repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 3 years, and then annually for 6 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: ixabepilone
  • Procedure: adjuvant therapy
  • Radiation: intensity-modulated radiation therapy
Study Arms  ICMJE Experimental: ixabepilone
Adjuvant therapy
Interventions:
  • Drug: ixabepilone
  • Procedure: adjuvant therapy
  • Radiation: intensity-modulated radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 19, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2010)
54
Actual Study Completion Date  ICMJE October 17, 2011
Actual Primary Completion Date October 17, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Diagnosis of adenocarcinoma of the prostate

    • Must have undergone any common form of prostatectomy (e.g., open, perineal, laparoscopic, or robotic) within the past 2 years
    • T3 disease or positive surgical margins
    • Node negative (N0) and free of distant metastasis (M0) by a bone scan and CT scan or MRI of the pelvis within the past 90 days
    • Considered high-risk disease
  • Gleason score = 7 and post-operative PSA > 0 and ≤ 2 ng/mL OR Gleason score ≥ 8 and post-operative PSA ≥ 0 and ≤ 2 ng/mL
  • Pre-prostatectomy PSA available

    • Range of pre-prostatectomy PSA values not required

PATIENT CHARACTERISTICS:

  • Zubrod (ECOG) performance status 0-1
  • ANC ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8 g/dL
  • Total bilirubin < 1.5 times upper limit of normal (ULN)
  • AST and ALT < 2.5 times ULN
  • Alkaline phosphatase < 2.5 times ULN
  • Fertile patients must use effective contraception during and for 4 weeks after completion of study therapy
  • Patients with urinary incontinence waiting for stabilization of urinary function after prostatectomy allowed for up to 6 months
  • No CTCv4 peripheral neuropathy (motor or sensory) ≥ grade 1
  • No history of inflammatory colitis including Crohn disease or ulcerative colitis
  • No significant history of psychiatric illness
  • No other invasive malignancy within the past 3 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the oral cavity
  • No severe, active co-morbidity with any of the following:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring IV antibiotics
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days
    • Immunocompromised patients or AIDS based upon current CDC definition

      • HIV testing not required
  • No history of hypersensitivity reactions to agents containing Cremophor® EL or its derivatives (e.g., polyoxyethylated castor oil)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior pelvic radiotherapy or radiotherapy for another malignancy that encompasses ≥ 30% of major bone marrow-containing areas (e.g., pelvis or lumbar spine)
  • No prior hormonal therapy for prostate cancer

    • Prior hormonal agents, e.g., finasteride or dutasteride, for benign prostatic hypertrophy allowed
  • No other concurrent adjuvant antineoplastic therapy planned while on this protocol, including the following:

    • Cryotherapy
    • Hormonal therapy
    • Other chemotherapy for prostate cancer

      • Prior chemotherapy for a different type of cancer allowed provided it was administered > 3 years ago
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01079793
Other Study ID Numbers  ICMJE SCCC-09809
CDR0000666842 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: David A. Pistenmaa, MD Simmons Cancer Center
PRS Account University of Texas Southwestern Medical Center
Verification Date March 2019

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