A Study of Pertuzumab in Participants With Prostate Cancer

• Status: Terminated
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study will evaluate the efficacy and safety of intravenous (IV) pertuzumab in participants with hormone-refractory prostate cancer who have had no previous chemotherapy. Participants will be enrolled in two stages, the first (Cohort A) at a lower 420-mg dose and the second (Cohort B) at a higher 1050-mg dose based upon observations in Cohort A. Up to 50 participants may enter either cohort, for a total enrollment between 46 and 73 participants across 9 study centers.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Pertuzumab

Criteria

Inclusion Criteria:

• Adults greater than (>) 18 years of age

• Histologically documented adenocarcinoma of the prostate resistant to hormone therapy, progressed at 4 to 6 weeks following anti-androgen withdrawal

• Prostate-specific antigen (PSA) values at least 20 ng/mL among those with asymptomatic or mildly symptomatic disease

• Karnofsky performance status (KPS) at least 80 percent (%)

• Castrate testosterone less than (<) 50 ng/dL

• Life expectancy at least 12 weeks

• Left ventricular ejection fraction (LVEF) at least 50%

• Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

• Prior chemotherapy, radionucleotide therapy, or immunotherapy for prostate cancer

• Systemic corticosteroids within 1 month prior to Screening

• Bisphosphonates within 6 months, narcotic analgesics within 2 weeks, or any investigational agent with 28 days of study drug

• Prior cumulative doxorubicin dose of > 360 mg/m^2 or equivalent

• Central nervous system (CNS) or pulmonary metastases

• Other malignancies, except adequately treated basal or squamous cell skin cancer

• Significant cardiovascular disease

• Active/uncontrolled concurrent illness or infection

• Major surgery or traumatic injury within 4 weeks of study drug