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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Velcade
LH-RH Agonist
Androgen Receptor Antagonists
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center
  • Hollings Cancer Center at Medical University of South Carolina
  • South Carolina Oncology Associates, PA
  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part A: Velcade

Part B: Velcade+LH-RH antagonist+Androgen receptor antagonist

Arm Description

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.

Patient will start Part B after completing Part A or may be enrolled to part B only.

Outcomes

Primary Outcome Measures

Prostate-specific Antigen (PSA) Response
Time to PSA Progression
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

Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0
Disease-free Interval
This will only be analyzed if sample size warrants the analysis.

Full Information

First Posted
February 7, 2005
Last Updated
October 17, 2018
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT00103376
Brief Title
Bortezomib With or Without Hormone Therapy in Treating Patients With Relapsed Prostate Cancer
Official Title
VELCADE® (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Low Accrual
Study Start Date
October 2004 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: Velcade
Arm Type
Experimental
Arm Description
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.
Arm Title
Part B: Velcade+LH-RH antagonist+Androgen receptor antagonist
Arm Type
Experimental
Arm Description
Patient will start Part B after completing Part A or may be enrolled to part B only.
Intervention Type
Drug
Intervention Name(s)
Velcade
Other Intervention Name(s)
bortezomib
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
LH-RH Agonist
Intervention Description
given as a 3 month depo-injection
Intervention Type
Drug
Intervention Name(s)
Androgen Receptor Antagonists
Intervention Description
given orally daily for 3 months
Primary Outcome Measure Information:
Title
Prostate-specific Antigen (PSA) Response
Time Frame
3 months after the start of treatment
Title
Time to PSA Progression
Description
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.
Time Frame
From on study until time of PSA progression for up to two years
Secondary Outcome Measure Information:
Title
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
Title
Disease-free Interval
Description
This will only be analyzed if sample size warrants the analysis.
Time Frame
3 months after combined treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew S. Kraft, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gustavo Leone
Organizational Affiliation
Medical University of South Carolina, Hollings Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Loma Linda University Cancer Institute at Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
South Carolina Oncology Associates, PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States

12. IPD Sharing Statement

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

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