Status:
COMPLETED
A Study of BAY 43-9006 in Combination With Bicalutamide in Patients With Chemo-Naïve Hormone Refractory Prostate Cancer
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
Adenocarcinoma of the Prostate
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Purpose: To determine the efficacy of BAY 43-9006 in combination with bicalutamide in patients with chemo-naïve hormone-refractory prostate cancer. Hypothesis: That there will be PSA response when ...
Detailed Description
Justification: The biologic and clinical activity and tolerability of BAY 43-9006, the therapeutic needs of the proposed patient population, and the experimental evidence in support of targeting the ...
Eligibility Criteria
Inclusion
- Patients must have a histologic or cytologic diagnosis of adenocarcinoma of the prostate.
- Patients must have low-bulk asymptomatic metastatic or biochemical recurrent disease for which no curative therapy exists.
- Patients must have documented evidence of PSA progression while receiving androgen ablative therapy, i.e. must be hormone refractory.
- The PSA must be \> 5 μg/L at the time of study entry.
- ECOG performance status of 0 or 1.
- Age 18 years of age or older
- Patients must have a life expectancy of at least 12 weeks.
- Chemotherapy: No prior cytotoxic chemotherapy is permissible. Neoadjuvant or adjuvant chemotherapy is permissible provided it was \> 12 months prior to registration.
- Hormonal Therapy:
- Prior hormone therapy in the form of medical or surgical castration is required. Patients must be hormone refractory and have been previously and currently treated with androgen ablative therapy.
- Patients may have received up to one line of non-steroidal anti- androgens in combination with chemical or surgical castration. Use of prior Bicalutamide is restricted to less than 3 months of continuous usage. Patients must be off anti-androgens for at least 6 weeks prior to study entry.
- Radiation: Prior external beam radiation is permitted provided a minimum of 4 weeks has elapsed between the last dose and enrollment to the trial.
- Steroids. Current treatment with steroids ≤ an equivalent of prednisone 20 mg day is permitted.
- Men of childbearing potential must use an effective form of contraception i.e. double barrier method.
- Laboratory Requirements - within 7 days prior to enrollment Hematology: Hemoglobin ≥ 100g/L Neutrophils \> 1.5 x 109/L Platelets \> 100 x 109/L INR ≤ 1.5 x upper limit of normal Biochemistry: AST, ALT within normal limits Bilirubin within normal limits Serum creatinine ≤1.5 x upper limit of normal
- 15\. Patient consent must be obtained 16. Patients must be accessible for treatment and follow-up. 17. Protocol treatment is to begin within 5 working days of patient registration.
Exclusion
- Prior use of BAY 43-9006 or other VEGF/VEGFR or EGFR targeting agents.
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for \> 5 years.
- Patients with known brain metastases or leptomeningeal disease
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY 43-9006 or other agents used in the study.
- Other serious intercurrent illness or medical condition that might be aggravated by protocol treatment including:myocardial infarction within 6 months prior to study entry:
- myocardial infarction within 6 months prior to study entry
- congestive heart failure
- unstable angina
- cardiomyopathy
- unstable ventricular arrhythmia
- uncontrolled hypertension (systolic blood pressure ≥ 160, diastolic blood pressure ≥100)
- controlled psychotic disorders
- serious infections
- peptic ulcer disease
- history of bleeding diathesis
- Upper gastrointestinal or other conditions that would preclude compliance with oral medication.
- Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with BAY 43-9006. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
- Patients who require large amounts of narcotic therapy to control pain (e.g. morphine equivalent dose \> 30 mg/day) since these patients would more appropriately be offered systemic chemotherapy.
- Patients who require therapeutic anticoagulation.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00430235
Start Date
March 1 2007
Last Update
August 5 2010
Active Locations (1)
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1
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6