This phase II trial is studying how well cilengitide works in treating patients with prostate cancer. Cilengitide may stop the growth of prostate cancer by blocking blood flow to the tumor
PRIMARY OBJECTIVES: I. To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer. SECONDARY OBJECTIVES: I. To evaluate the safety of EMD121974 in patients with non-metastatic androgen-independent prostate cancer. II. To assess the change in the slope of Prostate Specific Antigen associated with EMD121974 in patients with non-metastatic androgen-independent prostate cancer. III. To assess response duration, time to progression and survival. TERTIARY OBJECTIVES: I. To determine the effects of integrin αvβ3 and αvβ5 inhibition on total circulating tumor and endothelial cells isolated from peripheral blood and bone marrow aspirates from patients with non-metastatic androgen-independent prostate cancer. II. To study the genotypic/phenotypic variances in circulating tumor cells in patients with non-metastatic androgen-independent prostate cancer before and after EMD121974 treatment. III. To develop a genetic profile by cDNA microarray analysis of circulating tumor cells isolated from patients with non-metastatic androgen-independent prostate cancer before and after integrin αvβ3 and αvβ5 inhibition. OUTLINE: This is an open-label, multicenter study. Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA \< 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Given IV
University of Michigan University Hospital
Ann Arbor, Michigan, United States
The Number of Patients With a PSA Decline of ≥50%
To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer. This measure defined as a drop in PSA of at least 50% from the final pre-treatment value.
Time frame: Up to 5 years
Median PSA Slope Difference
Median PSA slope difference was calculated between baseline and 6 months.
Time frame: Baseline to 6 months
The Number of Participants With at Least One Incident of Toxicity
Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients (16 patients were enrolled however one progressed prior to treatment) including the two ineligible patients.
Time frame: Up to 5 years
Median Survival Time
6 of 13 patients were alive at five years. The Median survival time was calculated for all patients.
Time frame: Up to 5 years
Mean Time to Progression of Prostate Cancer
Kaplan-Meier estimates of time to progression will be reported.
Time frame: Up to 5 years
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