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A Phase II Study of BAY 43-9006 in Combination With Bicalutamide in Patients With Chemo-Naïve Hormone Refractory Prostate Cancer

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Prostate

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Trial Information

A Phase II Study of BAY 43-9006 in Combination With Bicalutamide in Patients With Chemo-Naïve Hormone Refractory Prostate Cancer


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
VEGF/VEGFR and MAPK pathways in combination with androgen receptor blockade in prostate
cancer, provides a strong rationale for the proposed phase II trial to evaluate the
tolerability and anti-cancer activity of combined treatment with the non-steroidal
anti-androgen bicalutamide with the multi-targeted kinase inhibitor BAY 43-9006 in patients
with prostate cancer that is progressing after castration therapy.


The primary study objective is to define the efficacy (i.e. post treatment decrement in PSA
(PSA response)) of BAY 43-9006 in combination with bicalutamide in patients with chemo-naïve
hormone-refractory prostate cancer.

Secondary Objectives:

- To determine the safety and tolerability of BAY 43-9006 given in combination with
bicalutamide in patients with HRPC.

- To determine the time to treatment failure, PSA progression and disease progression in
HRPC patients treated with BAY 43-9006 in combination with bicalutamide.

- To determine objective response rates in HRPC patients with measurable disease treated
with BAY 43-9006 in combination with bicalutamide.

Research Method:

This is a phase II clinical trial in patients with androgen independent prostate cancer
which will evaluate the therapeutic activity and safety profile of BAY 43-9006 given orally
at the recommended phase II dose of 400 mg PO BID continuously in combination with
bicalutamide 50 mg PO daily continuously. Each 4 week period will be considered 1 cycle.
Doses will be adjusted for toxicity.

Statistical Analysis:

Primary Endpoint The primary endpoint for this study will be the rate of PSA-response of the
combination for patients with rising PSA post castration therapy.

Secondary Endpoints:

Secondary endpoints will include time to treatment failure, time to PSA progression,
duration of PSA response, median survival time, 1 year survival rate, objective tumor
response rate and stable disease rate as defined by the RECIST criteria, response duration,
and incidence of toxicities by NCI CTCAE.

Inclusion Criteria:

1. Patients must have a histologic or cytologic diagnosis of adenocarcinoma of the

2. Patients must have low-bulk asymptomatic metastatic or biochemical recurrent disease
for which no curative therapy exists.

3. Patients must have documented evidence of PSA progression while receiving androgen
ablative therapy, i.e. must be hormone refractory.

4. The PSA must be > 5 μg/L at the time of study entry.

5. ECOG performance status of 0 or 1.

6. Age 18 years of age or older

7. Patients must have a life expectancy of at least 12 weeks.

8. Chemotherapy: No prior cytotoxic chemotherapy is permissible. Neoadjuvant or adjuvant
chemotherapy is permissible provided it was > 12 months prior to registration.

9. 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.

10. Radiation: Prior external beam radiation is permitted provided a minimum of 4 weeks
has elapsed between the last dose and enrollment to the trial.

11. Steroids. Current treatment with steroids ≤ an equivalent of prednisone 20 mg day is

12. Men of childbearing potential must use an effective form of contraception i.e. double
barrier method.

13. 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

Exclusion Criteria:

1. Prior use of BAY 43-9006 or other VEGF/VEGFR or EGFR targeting agents.

2. 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.

3. Patients with known brain metastases or leptomeningeal disease

4. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to BAY 43-9006 or other agents used in the study.

5. Other serious intercurrent illness or medical condition that might be aggravated by
protocol treatment including:myocardial infarction within 6 months prior to study

- 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

6. Upper gastrointestinal or other conditions that would preclude compliance with oral

7. 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.

8. 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.

9. Patients who require therapeutic anticoagulation.

Type of Study:


Study Design:

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

Outcome Measure:

rate of PSA-response

Principal Investigator

Kim N Chi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

British Columbia Cancer Agency


Canada: Health Canada

Study ID:




Start Date:

March 2007

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • prostate
  • cancer
  • BAY 43-9006
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms