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Bortezomib With or Without Hormone Therapy in Treating Patients With Relapsed Prostate Cancer

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: NCT00103376
Recruitment Status : Terminated (Low Accrual)
First Posted : February 8, 2005
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, leuprolide, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Giving bortezomib with hormone therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bortezomib with or without hormone therapy works in treating patients with relapsed prostate cancer.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Velcade Drug: LH-RH Agonist Drug: Androgen Receptor Antagonists Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VELCADE® (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer
Study Start Date : October 2004
Actual Primary Completion Date : October 2009
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Bortezomib

Arm Intervention/treatment
Experimental: Part A: Velcade
Patient will complete Part A (Velcade only). If the patient has a complete response, he will come off study. If the patient has progressive disease, he will start Part B (Velcade + antiandrogen). If the patient has a partial response or stable disease, he will start Part B after at least a 7-day break.
Drug: Velcade

Part A: 1.3 mg/m2 administered on days 1, 4, 8 and 11 followed by 10 days rest. A second cycle will be given at the same schedule. Cycle 3 will include 3 weekly injections.

Part B: 1.3mg/m2 administered weekly for 3 weeks followed by 1 week break

Other Name: bortezomib

Experimental: Part B: Velcade+LH-RH antagonist+Androgen receptor antagonist
Patient will start Part B after completing Part A or may be enrolled to part B only.
Drug: Velcade

Part A: 1.3 mg/m2 administered on days 1, 4, 8 and 11 followed by 10 days rest. A second cycle will be given at the same schedule. Cycle 3 will include 3 weekly injections.

Part B: 1.3mg/m2 administered weekly for 3 weeks followed by 1 week break

Other Name: bortezomib

Drug: LH-RH Agonist
given as a 3 month depo-injection

Drug: Androgen Receptor Antagonists
given orally daily for 3 months




Primary Outcome Measures :
  1. Prostate-specific Antigen (PSA) Response [ Time Frame: 3 months after the start of treatment ]
  2. Time to PSA Progression [ Time Frame: From on study until time of PSA progression for up to two years ]
    PSA progression is defined as a PSA increase of 50% over the nadir CR or CR/PR value on three successive PSA measurements two months apart to a value of >= 1.0 ng/ml.


Secondary Outcome Measures :
  1. Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0 [ Time Frame: From start of treatment until end of study, up to 6 months ]
  2. Disease-free Interval [ Time Frame: 3 months after combined treatment ]
    This will only be analyzed if sample size warrants the analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Relapsed disease after definitive local therapy, as documented only by a rise in prostate-specific antigen (PSA)

    • Experienced PSA relapse after definitive local therapy
    • Rising PSA (≥ 1.0 ng/mL after nadir < 1.0 ng/mL)

      • PSA increase of ≥ 0.3 ng/mL (increase occurred between 2 separate measurements taken ≥ 4 weeks apart)
    • The first of these two PSA values must rise above a previously recorded post-therapy nadir value
  • Ineligible for curative therapy
  • No clinical evidence of local recurrence (i.e., palpable induration or mass in the prostatic fossa) other than PSA elevation
  • No evidence of palpable disease in the prostatic bed
  • No metastatic disease (M0)

    • No non-nodal (> N1) metastasis
    • No evidence of osseous metastasis on bone scan within the past 28 days

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-1

Life expectancy

  • At least 1 year

Hematopoietic

  • Platelet count ≥ 30,000/mm^3
  • Absolute neutrophil count ≥ 1,000/mm^3

Hepatic

  • No known hepatitis B or C positivity

Renal

  • Creatinine clearance ≥ 30 mL/min

Immunologic

  • No known human T-cell lymphotropic virus positivity
  • No hypersensitivity to bortezomib, boron, or mannitol
  • No known HIV 1 or 2 positivity
  • No active, ongoing bacterial, viral, or fungal infection

Other

  • Fertile patients must use effective contraception
  • No peripheral neuropathy ≥ grade 2
  • No other disease, condition, or social or geographic constraint that would preclude study participation
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 6 months since prior hormonal therapy combined with radiation therapy as definitive therapy
  • Neoadjuvant hormonal therapy prior to definitive therapy (e.g., surgery, radiation therapy, brachytherapy, or cryoablation) allowed
  • No other concurrent hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • More than 12 months since prior radioactive seed therapy
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • More than 4 weeks since prior surgery
  • No concurrent surgery

Other

  • No concurrent second-line herbal preparations, including PC-SPES
  • No other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103376


Locations
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United States, California
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Andrew S. Kraft, MD Medical University of South Carolina
Study Chair: Gustavo Leone Medical University of South Carolina, Hollings Cancer Center

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00103376    
Other Study ID Numbers: CDR0000406013
MUSC-031218
MUSC-HR-11357
First Posted: February 8, 2005    Key Record Dates
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018
Last Verified: October 2018
Keywords provided by Medical University of South Carolina:
adenocarcinoma of the prostate
recurrent prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bortezomib
Androgens
Androgen Receptor Antagonists
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists