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| ID | Type | Description | Link |
|---|---|---|---|
| MUSC-031218 | |||
| MUSC-HR-11357 |
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Low Accrual
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Velcade | Experimental | 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. |
|
| Part B: Velcade+LH-RH antagonist+Androgen receptor antagonist | Experimental | Patient will start Part B after completing Part A or may be enrolled to part B only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Velcade | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate-specific Antigen (PSA) Response | 3 months after the start of treatment | |
| 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. | From on study until time of PSA progression for up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0 | From start of treatment until end of study, up to 6 months | |
| Disease-free Interval | This will only be analyzed if sample size warrants the analysis. |
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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)
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)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Andrew S. Kraft, MD | Medical University of South Carolina | Principal Investigator |
| Gustavo Leone | Medical University of South Carolina, Hollings Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California | 92354 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A Only: Velcade | Patients who were enrolled to Part A but did not move on to Part B |
| FG001 | Part B (Velcade+LH-RH Antagonist+Adrogen Receptor) | Patients who were enrolled only to part B. |
| FG002 | Part A + Part B | Patients who completed part A and moved in to Part B. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A Only: Velcade | Patients who were enrolled to Part A but did not move on to Part B. |
| BG001 | Part B (Velcade + LH-RH Antagonist+Androgen Receptro | Patients who were enrolled only to part B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prostate-specific Antigen (PSA) Response | Posted | Number | participants | 3 months after the start of treatment |
|
from start of treatment until end of study visit, about 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: Velcade Only | Patients who were enrolled to Part A but did not move on to Part B |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neuropathy | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kate Anderton | Medical University of South Carolina | 843-792-2708 | anderton@musc.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D007987 | Gonadotropin-Releasing Hormone |
| D059002 | Androgen Receptor Antagonists |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| LH-RH Agonist | Drug | given as a 3 month depo-injection |
|
| Androgen Receptor Antagonists | Drug | given orally daily for 3 months |
|
| 3 months after combined treatment |
| Hollings Cancer Center at Medical University of South Carolina |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| South Carolina Oncology Associates, PA | Columbia | South Carolina | 29210 | United States |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| BG002 | Part A + Part B | Patients who completed part A and moved in to part B. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Only patients with a CR were included in the analysis. No patients in Part A had a complete response. Time to progression for Part B only and Part A+Part B was calculated together. The information for the confidence interval is not available. | Posted | Median | 95% Confidence Interval | months | From on study until time of PSA progression for up to two years |
|
|
|
| Secondary | Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0 | Posted | Number | participants | From start of treatment until end of study, up to 6 months |
|
|
|
| Secondary | Disease-free Interval | This will only be analyzed if sample size warrants the analysis. | data was not collected for this outcome measure. | Posted | 3 months after combined treatment |
|
|
| 1 |
| 8 |
| 8 |
| 8 |
| EG001 | Part B (Velcade+LH-RH Antagonist+Adrogen Receptor) | Patients who were enrolled only to part B. | 0 | 7 | 7 | 7 |
| EG002 | Part A + Part B | Patients who completed part A and moved in to Part B. | 0 | 8 | 8 | 8 |
| fatigue | General disorders |
|
| anemia | Blood and lymphatic system disorders |
|
| thrombocytopenia | Blood and lymphatic system disorders |
|
| neutropenia | Blood and lymphatic system disorders |
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| constipation | Gastrointestinal disorders |
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| ileus | Gastrointestinal disorders |
|
| anorexia | General disorders |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| weakness | Musculoskeletal and connective tissue disorders |
|
| infection | Infections and infestations |
|
| vomiting | Gastrointestinal disorders |
|
| shingles | Infections and infestations |
|
| pain | General disorders |
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| hypotension | Vascular disorders |
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| dizziness | General disorders |
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| insomnia | Psychiatric disorders |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000726 | Androgen Antagonists |
| D006727 | Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |