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



Status:Terminated
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:11/7/2018
Start Date:October 2004
End Date:June 2011

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VELCADE® (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer

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.


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
We found this trial at
4
sites
101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Gibbs Cancer Center is a nationally...
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Spartanburg, SC
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86 Jonathan Lucas Street
Charleston, South Carolina 29425
(843) 792-0700
Hollings Cancer Center at Medical University of South Carolina Located at the Medical University of...
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Charleston, SC
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166 Stoneridge Drive
Columbia, South Carolina 29210
803-461-3000
South Carolina Oncology Associates, PA South Carolina Oncology Associates (SCOA) is the only comprehensive cancer...
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Columbia, SC
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11234 Anderson Street
Loma Linda, California 92354
(909) 558-4126
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda University Cancer...
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from
Loma Linda, CA
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