Status:
TERMINATED
Bortezomib With or Without Hormone Therapy in Treating Patients With Relapsed Prostate Cancer
Lead Sponsor:
Medical University of South Carolina
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE2
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, leup...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00103376
Start Date
October 1 2004
End Date
June 1 2011
Last Update
November 5 2018
Active Locations (4)
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1
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
2
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
3
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
4
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303