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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

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 CenterLoma Linda, California  92354
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
South Carolina Oncology Associates, PAColumbia, South Carolina  29210