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Phase II Study of Erlotinib in Patients With Non-Metastatic Prostate Cancer With a Rising PSA on Hormone Therapy


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Phase II Study of Erlotinib in Patients With Non-Metastatic Prostate Cancer With a Rising PSA on Hormone Therapy


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 patients are treated with hormone therapy. After a fall in
the PSA, these patients eventually display evidence of tumor progression clearly
demonstrated by another rise in PSA level while receiving hormone therapy. Evaluation for
evidence of tumor spread is usually negative. There is currently no effective therapy
approved for use in these patients.

The drug erlotinib works by blocking the activity of a protein called Epidermal Growth
Factor Receptor (EGFR), which is located on the surface of many prostate cancer cells.
Blockage of this protein has been shown to inhibit the growth of prostate tumor cells in a
laboratory setting and in animal experiments. Erlotinib has been given to patients with
other types of cancers. A recently completed study showed that erlotinib improved the
survival of patients with advanced lung cancer who failed standard chemotherapy.

There is currently no effective therapy approved for use in patients with this condition.
The purpose of this study is to evaluate the effectiveness and side effects of the drug
erlotinib in patients with this condition. Erlotinib is an investigational drug that has
not yet been approved by the Federal Drug Administration (FDA) for use in prostate cancer,
but has been approved for use in lung cancer.

As previously stated: 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.

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 EGFR-related proteins using baseline immunohistochemical (IHC) studies on tissue
blocks and peripheral blood mononuclear cells.


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Principal Investigator

Daniel Shevrin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NorthShore University HealthSystem Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

OSI3316s

NCT ID:

NCT00148772

Start Date:

August 2005

Completion Date:

August 2008

Related Keywords:

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

Name

Location

Evanston Northwestern HealthcareEvanston, Illinois  60201
Northwestern UniversityChicago, Illinois  60611