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

NCT00103376 | Terminated Phase 2 Results DMC

• 3 other identifiers: CDR0000406013MUSC-031218MUSC-HR-11357
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

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

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• 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

  3 months after combined treatment

Study Arms (2)

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.

Drug: Velcade

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.

Drug: Velcade; Drug: LH-RH Agonist; Drug: Androgen Receptor Antagonists

Interventions

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

Also known as: bortezomib

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

LH-RH Agonist DRUG

given as a 3 month depo-injection

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

Androgen Receptor Antagonists DRUG

given orally daily for 3 months

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (4)

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

South Carolina Oncology Associates, PA

Columbia, South Carolina, 29210, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Bortezomib; Gonadotropin-Releasing Hormone; Androgen Receptor Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Androgen Antagonists; Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Kate Anderton
• Organization: Medical University of South Carolina

anderton@musc.edu

843-792-2708

Study Officials

• Andrew S. Kraft, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Gustavo Leone

  Medical University of South Carolina, Hollings Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2005
• First Posted: February 8, 2005
• Study Start: October 1, 2004
• Primary Completion: October 1, 2009
• Study Completion: June 1, 2011
• Last Updated: November 5, 2018
• Results First Posted: November 5, 2018

Record last verified: 2018-10

Locations

US (4)