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

NCT ID: NCT00103376

Last Updated: 2018-11-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2011-06-30

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, 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: Velcade

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.

Group Type: EXPERIMENTAL

Velcade

Intervention Type: 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

Part B: Velcade+LH-RH antagonist+Androgen receptor antagonist

Patient will start Part B after completing Part A or may be enrolled to part B only.

Group Type: EXPERIMENTAL

Velcade

Intervention Type: 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

LH-RH Agonist

Intervention Type: DRUG

given as a 3 month depo-injection

Androgen Receptor Antagonists

Intervention Type: DRUG

given orally daily for 3 months

Interventions

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

Intervention Type: DRUG

LH-RH Agonist

given as a 3 month depo-injection

Intervention Type: DRUG

Androgen Receptor Antagonists

given orally daily for 3 months

Intervention Type: DRUG

Other Intervention Names

bortezomib

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew S. Kraft, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Gustavo Leone

Role: STUDY_CHAIR

Medical University of South Carolina, Hollings Cancer Center

Locations

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 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

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Countries

United States

Other Identifiers

MUSC-031218

Identifier Type: -

Identifier Source: secondary_id

MUSC-HR-11357

Identifier Type: -

Identifier Source: secondary_id

CDR0000406013

Identifier Type: -

Identifier Source: org_study_id