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Clinical Cancer Research Vol. 7, 800-805, April 2001
© 2001 American Association for Cancer Research

Molecular Oncology, Markers, Clinical Correlates

A Multi-Institutional Phase II Study of SU101, a Platelet-derived Growth Factor Receptor Inhibitor, for Patients with Hormone-Refractory Prostate Cancer1

Yoo-Joung Ko, Eric J. Small, Fairooz Kabbinavar, Abraham Chachoua, Samir Taneja, David Reese, Ann DePaoli, Alison Hannah, Steven P. Balk and Glenn J. Bubley2

Beth Israel Deaconess Medical Center, Harvard Medical School Boston, Massachusetts 02215 [Y-J. K., S. P. B., G. J. B.]; University of California–San Francisco, San Francisco, California 94143 [E. J. S., D. R.]; University of California–Los Angeles, Los Angeles, California 90095 [F. K.]; New York University Medical Center, New York, New York 10016 [A. C., S. T.]; and Sugen, South San Francisco, California 94080 [A. D., A. H.]

In a multi-institutional Phase II trial, we evaluated the efficacy of a platelet-derived growth factor receptor (PDGF-r) inhibitor, SU101, in patients with hormonerefractory prostate cancer. The patients received a 4-day i.v. loading dose of SU101 at 400 mg/m2 for 4 consecutive days, followed by 10 weekly infusions at 400 mg/m2. The primary study end points were a decline in prostate-specific antigen (PSA) and a decrease in measurable tumor. Secondary end points were time to progression and an effect on pain as measured by the Brief Pain Survey. Expression of PDGF-r was examined in both metastatic and archival primary prostate tumor samples. Forty-four patients were enrolled at four centers. The median age was 72 years, the median PSA was 223 ng/ml, and 21 patients had at least one prior chemotherapy. Thirty-nine patients are evaluable for PSA, and three patients demonstrated a PSA decline >50% from baseline (55–99.9% decrease). The median time to progression was 90 days. Of 19 patients evaluable for measurable disease, 1 patient had a partial response. Nine of 35 evaluable patients had significant improvement in pain. The most frequent adverse events were asthenia (75%), nausea (55%), anorexia (50%), and anemia (41%). PDGF-r expression was detected in 80% of the metastases and 88% of primary prostate cancers. The results of this trial may warrant further clinical studies with other PDGF-r inhibitors.




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