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A Phase II Trial of Bryostatin 1 in the Treatment of Metastatic Colorectal Cancer
Ist Teil von
Clinical cancer research, 2001-01, Vol.7 (1), p.38-42
Ort / Verlag
Philadelphia, PA: American Association for Cancer Research
Erscheinungsjahr
2001
Quelle
MEDLINE
Beschreibungen/Notizen
Current chemotherapy for patients with advanced colorectal cancer is
relatively ineffective and may be associated with significant toxicity.
Bryostatin 1 (bryo 1) influences cell proliferation, intracellular
metabolism and signaling, differentiation, and apoptosis in human
cancer cell lines via modulation of protein kinase C (PKC) activity.
This trial investigates the efficacy and toxicity of bryo 1 as a novel
therapeutic agent for patients with advanced colorectal cancer who have
had previous 5-fluorouracil therapy. The primary end point was tumor
response to bryo 1. Toxicity was also assessed. Twenty-eight patients
with advanced colorectal cancer were enrolled. The mean age was 59
years (range, 38–76), with 16 men and 12 women, and good minority
representation (11 African-Americans). The first 10 patients initially
received 25 μg/m 2 of bryo 1 weekly as a 24-h infusion for
3 weeks of every 4-week cycle, with dose escalation to 35μ
g/m 2 starting with the second cycle. The remaining
patients were started at 35 μg/m 2 and escalated to 40μ
g/m 2 , if toxicity was minimal. Twenty-five patients were
evaluable for objective tumor response, and complete data on toxicity
were collected on 26 patients. No partial or complete tumor responses
were observed. All 25 patients had disease progression within four
cycles. Myalgia was the most common toxicity. Myelosuppression was not
seen. bryo 1 as a weekly 24-h continuous infusion lacks single-agent
antitumor activity in advanced colorectal cancer. Toxicity differs from
that of traditional chemotherapeutic drugs.