Status:
COMPLETED
Study of Erlotinib in Patients With Non-Metastatic Prostate Cancer With a Rising Prostate Specific Antigen (PSA) on Hormone Therapy
Lead Sponsor:
Endeavor Health
Collaborating Sponsors:
Genentech, Inc.
Northwestern University
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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. T...
Detailed Description
Patients with prostate cancer who are treated with surgery or radiation often develop recurrence of their cancer which is manifest only by a rising PSA (Prostate Specific Antigen) level. Many of these...
Eligibility Criteria
Inclusion
- 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.
- Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for the specific cancer.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00148772
Start Date
August 1 2005
End Date
August 1 2008
Last Update
June 28 2011
Active Locations (2)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201