Bicalutamide and RO4929097 in Treating Patients With Previously Treated Prostate Cancer

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer

In brief

This partially randomized phase II trial is studying how well giving bicalutamide together with RO4929097 works in treating patients with previously treated prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bicalutamide together with RO4929097 may be an effective treatment for prostate cancer

Key facts

Study ID

NCT01200810

Run by

National Cancer Institute (NCI)

People needed

10

Starts

2010-08-01

Expected to finish

2012-11-01

Last updated by the study team

2017-12-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed prostate cancer
• Stage D0 OR D1 disease (i.e., tumor originally diagnosed as being limited to the prostate and regional lymph nodes)
• Has a rising PSA value after definitive local therapy (i.e., prostatectomy or radiotherapy) and no radiographic evidence of disease
• PSA progression after local treatment:
• PSA values for patients after surgery must be ≥ 0.2 ng/mL, determined by two measurements, ≥ 1 month apart and ≥ 6 months after prostatectomy
• PSA values for patients after radiotherapy must be ≥ 2.0 ng/mL above the nadir PSA achieved after radiotherapy, determined by two measurements at 1 month apart and ≥ 6 months after completion of the radiotherapy treatment (patients who received adjuvant or salvage radiotherapy after prostatectomy must have PSA of ≥ 0.2 ng/mL)
• The first two PSA values, along with a third (study baseline) value must all be rising (i.e., there must be an overall rising trajectory, such that the third value cannot be lower than the first value)
• No metastatic disease on baseline bone scan and CT scan of the abdomen/pelvis
• ECOG performance status 0-2
• Life expectancy ≥ 6 months
• WBC ≥ 3,000/mm\^3
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL
• Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 40 mL/min for patients with creatinine levels above normal
• Bilirubin normal
• AST and/or ALT ≤ 2.5 times ULN
• Serum total testosterone level ≥ 150 ng/dL
• No uncontrolled electrolyte abnormalities including hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia, or hypokalemia, defined as less than the lower limit of normal despite adequate electrolyte supplementation
• Fertile patients must use two effective forms of contraception (i.e., barrier contraception and one other method of contraception) for 1 week before, during, and for ≥ 12 months after completion of study treatment
• Able to swallow tablets
• No malabsorption syndrome or other condition that would interfere with intestinal absorption
• No uncontrolled concurrent illness including, but not limited to, any of the following:
• Ongoing or active infection
• Symptomatic congestive heart failure

Where it is running

• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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