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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00103376
• Other study ID #: CDR0000406013
• Secondary ID: MUSC-031218MUSC-
• Status: Terminated
• Phase: Phase 2
• Start date: October 2004
• Est. completion date: June 2011

Study information

• Verified date: October 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: June 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Velcade
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
• LH-RH Agonist
given as a 3 month depo-injection
• Androgen Receptor Antagonists
given orally daily for 3 months

Locations

Country	Name	City	State
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	South Carolina Oncology Associates, PA	Columbia	South Carolina
United States	Loma Linda University Cancer Institute at Loma Linda University Medical Center	Loma Linda	California
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate-specific Antigen (PSA) Response		3 months after the start of treatment
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.	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		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.	3 months after combined treatment