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[Proceedings of the 11th NCI EORTC AACR Symposium]
Copyright 2000 Stichting NCI-EORTC Symposium on New Drugs in Cancer Therapy Published by the AACR.

285 Thalidomide, an angiogenesis inhibitor, has activity in metastatic prostate cancer.

Figg WD, Dahut W, Libutti SK, Carrasquillo J, Bacharach S , Kurdziel K, Huebsch F, Kruger EA, Pluda J, and Reed E. Medicine Branch, National Cancer Institute, NIH, Bethesda, MD USA.

We have completed an open-label, phase II, randomized study of thalidomide in patients with androgen-independent prostate cancer (AIPC). A total of 63 patients were enrolled into a low dose arm (200 mg/day; 50 individuals) or high dose arm (200 mg/day escalating to a maximum 1200 mg/day; 13 individuals). Restaging imaging studies were performed bimonthy. PSA measurements were taken monthly. Additionally, the tumor blood flow, volume and metabolism of six individuals were followed by PET scanning using H2015, 11CO and 18FDG. Results: Decline in PSA was seen in 58% of low dose patients versus 68% for high dose patients. PSA declines >50% were seen in 18% of low dose patients, four or which maintained depressed PSA levels for > 150 days. Two patients receiving 200 mg/day were deemed partial responders by bone scan criteria. Four patients receiving drug for > 9 months developed symptoms of peripheral neuropathy. PET scans taken at baseline and 2 or 6 months for all 6 individuals tested showed a change in PET 18FDG measurements in bone or soft tissue lesions that were similar to changes in PSA.

Conclusions: We conclude from this data that thalidomide not only has effects on PSA levels, but may also demonstrate effects on tumor metabolism and metabolic volume as measured by PET. We are currently conducting two additional phase II studies of thalidomide: 1) a randomized trial of docetaxel with or without thalidomide in AIPC and 2) a randomized crossover, placebo-controlled study of intermittent androgen ablation with thalidomide in patients with PSA-only disease following definitive therapy (Stage D0 prostate cancer).

Published as a Supplement to Clinical Cancer Research
Volume 6, November 2000
ISSN 1078-0432

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