VELCADE® (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
VELCADE® (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer
OBJECTIVES:
Primary
- Determine the prostate-specific antigen (PSA) relapse after an observed rise in
testosterone after combination treatment with hormone blockade and bortezomib.
Secondary
- Determine the safety of this drug in combination with combined androgen blockade
therapy in these patients.
- Determine the disease-free interval in patients treated with this regimen.
- Determine time to tsetosterone rise in patients treated wtih this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive androgen blockade therapy comprising a 3-month subcutaneous injection of
goserelin OR leuprolide OR other FDA-approved method of primary androgen suppression AND
oral flutamide or bicalutamide once daily for 3 months. Patients also receive bortezomib IV
over 3-5 seconds on days 1, 8, and 15. Treatment with bortezomib repeats every 28 days for 3
courses. Patients achieving a CR discontinue treatment and are observed for PSA or
metastatic disease recurrence. Patients with a PR or stable disease receive additional
combined androgen blockade therapy and 3 additional courses of bortezomib as above. Patients
with progressive disease are removed from the study.
Patients are followed every 3 months for up to 5 years.
PROJECTED ACCRUAL: A total of 21-42 patients will be accrued for this study.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Prostate-specific antigen (PSA) response as measured by complete or partial response, stable or progressive disease 3 months after initial treatment
Safety Issue:
No
Principal Investigator
Andrew S. Kraft, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical University of South Carolina
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000406013
NCT ID:
NCT00103376
Start Date:
October 2004
Completion Date:
June 2011
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- recurrent prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| South Carolina Oncology Associates, PA | Columbia, South Carolina 29210 |
