Study of Erlotinib in Patients With Non-Metastatic Prostate Cancer With a Rising Prostate Specific Antigen (PSA) on Hormone Therapy

NCT00148772 | Completed Phase 2

• 1 other identifier: OSI3316s
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this study is to evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy. The secondary objectives are to evaluate the effect of erlotinib on the duration of PSA response, to evaluate the effect on the time to PSA progression, to evaluate the toxicity of erlotinib in this patient population, and lastly, to correlate the effect of erlotinib with various epidermal growth factor receptor (EGFR)-related proteins using baseline immunohistochemical (IHC) studies on tissue blocks and peripheral blood mononuclear cells.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Rising PSA; Erlotinib; Tarceva; Androgen Deprivation Therapy; Hormone Therapy; Rising Prostate Specific Antigen (PSA); Non-Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy

Secondary Outcomes (4)

• To evaluate the effect of erlotinib on the duration of PSA response

• To evaluate the effect of erlotinib on the time to PSA progression

• To evaluate the toxicity of erlotinib in this patient population

• To correlate the effect of erlotinib with various EGFR downstream proteins and androgen receptor, using baseline IHC studies on tissue blocks and analysis of protein phosphorylation in peripheral blood mononuclear cells

Interventions

Erlotinib (Tarceva) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have documented adenocarcinoma of the prostate, treated with androgen suppression, and now present with a rising PSA .
• Prior therapy with hydrocortisone is allowed (must have discontinued \> 4 weeks prior to study treatment). Prior use of ketoconazole for prostate cancer treatment is allowed (must have discontinued \> 4 weeks prior to study treatment).
• Prior therapy with chemotherapy is allowed if it was administered as neoadjuvant or adjuvant therapy related to primary treatment and was completed \> 6 months prior to starting study treatment.
• Testosterone level \< 50 ng/dl within 4 weeks prior to study treatment. Patients who have not undergone surgical castration must continue primary androgen suppression therapy (luteinizing hormone-releasing hormone \[LHRH\] agonist) while on protocol therapy.
• Patients may be receiving oral bisphosphonate therapy prior to study treatment and continue while receiving treatment, but must not begin treatment with bisphosphonate while receiving study treatment. Patients on oral bisphosphonates must have completed at least 4 weeks of bisphosphonate therapy prior to study treatment.
• Patients must have adequate major organ function. All values must be obtained within 4 weeks prior to study treatment.
• Creatinine \< 1.7 mg/dL or a creatinine clearance \> 50 mL/min,
• SGOT (AST), SGPT (ALT) \< 2X the institution's upper limit of normal,
• Bilirubin \< 1.5 mg/dL,
• ANC \> 1500/mm3,
• Platelet (PLT) \> 100,000/mm3
• Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
• Patients must be \> 18.
• Patients taking warfarin are eligible.
• Patients taking CYP3A4 inducers or inhibitors are eligible.

You may not qualify if:

• No previous palliative radiation. Prior radiation to the primary site is allowed.
• HIV positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with erlotinib.
• Patients with gastrointestinal tract disease resulting in an inability to take oral medication are ineligible.
• Patients must not have ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements.
• Patients must not have received prior targeted therapy, including no prior EGFR inhibitor.
• Patients must not have evidence of metastatic disease.

Sponsors & Collaborators

• Endeavor Health: lead
• Genentech, Inc.: collaborator
• Northwestern University: collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Evanston Northwestern Healthcare

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Erlotinib Hydrochloride

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)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Daniel Shevrin, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: August 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: June 28, 2011

Record last verified: 2005-08

Locations

US (2)