Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

NCT00093457 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: I167CAN-NCIC-IND167CDR0000387987
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 7

Brief Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying the effectiveness of sorafenib in treating patients who have metastatic or recurrent prostate cancer that has not responded to previous hormone therapy.

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer; stage IV prostate cancer; adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

• Prostate-specific antigen response and/or progression

  2 years

Secondary Outcomes (3)

• Objective response and/or progression

  2 years

• Tolerability and toxicity

  2 years

• Time to treatment failure and overall patient survival

  2 years

Interventions

sorafenib tosylate DRUG

BAY 43-9006 given orally at 400 mg BID in a 28 day cycle

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 * Metastatic or recurrent disease * No curative standard therapy exists * Hormone-refractory disease * Evidence of prostate-specific antigen (PSA) progression during androgen ablation therapy, including medical or surgical castration * Documented PSA progression after completion of prior peripheral anti-androgens * At least a 25% increase (≥ 5 ng/mL) over a reference value PSA with 2 consecutive rising PSAs taken ≥ 1 week apart * Castrate level of testosterone ≤ 1.7 nmol/L for patients on medical androgen ablation * Patients receiving luteinizing hormone-releasing hormone agonist therapy must continue this treatment during study participation * PSA ≥ 10 ng/mL at the time of study entry * Primary tumor tissue (paraffin embedded) must be available for immunohistochemistry * Minimal symptomatic disease * No requirement for morphine or equivalent dose \> 30 mg/day to control pain * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * At least 12 weeks Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * No evidence of bleeding diathesis Hepatic * Bilirubin normal * AST and ALT ≤ 2.5 times upper limit of normal Renal * Serum creatinine normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * No myocardial infarction within the past 6 months * No congestive heart failure * No unstable angina * No active cardiomyopathy * No unstable ventricular arrhythmia * No uncontrolled hypertension Other * No serious infection * No active peptic ulcer disease * No upper gastrointestinal or other condition that would preclude study compliance with oral medication * No uncontrolled psychotic disorder * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to sorafenib or other study agents * No other serious illness or medical condition that would preclude study participation * No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or other curatively treated solid tumor PRIOR CONCURRENT THERAPY: Biologic therapy * Concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or other growth factors allowed for the management of adverse events only Chemotherapy * No prior chemotherapy * No other prior cytotoxic chemotherapy Endocrine therapy * See Disease Characteristics * Concurrent steroids allowed provided there has been no increase in steroid requirements within the past 4 weeks AND no increase in dose is planned Radiotherapy * At least 4 weeks since prior external-beam radiotherapy except low-dose non-myelosuppressive radiotherapy * Concurrent low-dose non-myelosuppressive palliative radiotherapy allowed Surgery * Not specified Other * No prior investigational anticancer agents * No concurrent therapeutic anticoagulation * Concurrent prophylactic low-dose warfarin for venous or arterial access devices allowed * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent anticancer therapy * No other concurrent investigational therapy * No concurrent grapefruit juice * Concurrent bisphosphonates allowed

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

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Chi KN, Ellard SL, Hotte SJ, Czaykowski P, Moore M, Ruether JD, Schell AJ, Taylor S, Hansen C, Gauthier I, Walsh W, Seymour L. A phase II study of sorafenib in patients with chemo-naive castration-resistant prostate cancer. Ann Oncol. 2008 Apr;19(4):746-51. doi: 10.1093/annonc/mdm554. Epub 2007 Dec 3.

  PMID: 18056648 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sorafenib

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)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Kim N. Chi, MD

  British Columbia Cancer Agency

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 6, 2004
• First Posted: October 8, 2004
• Study Start: August 10, 2004
• Primary Completion: September 28, 2006
• Study Completion: January 18, 2011
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)