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188Re-HEDP combined with capecitabine in hormone-refractory prostate cancer patients with bone metastases
European Journal of Nuclear Medicine & Molecular Imaging, 04/03/09

Lam MGEH et al. - In a trial to assess the use of combination of 188Re-HEDP and capecitabine in hormone-refractory prostate cancer (HRPC) pts with bone metastases, it was reported that capecitabine may be safely used in combination with 188Re-HEDP in a dose of 2500 mg/m2 per day and 37 MBq/kg, respectively.

Methods

Pts with HRPC were treated with capecitabine for 14 days (oral twice daily in a dose escalation regimen with steps of 1/3 of 2500 mg/m2 per day in cohorts of 3 to 6 pts, depending on toxicity).
2 days later, pts were treated with 37 MBq/kg 188Re-HEDP as an intravenous injection.
6 hrs after treatment, post-therapy scintigraphy was performed.
Urine was collected for 8 hr post-injection.
Follow-up was at least 8 wks.
Primary endpoint was to establish maximum tolerable dose (MTD) of capecitabine when combined with 188Re-HEDP.
Secondary endpoints included effect of capecitabine on the biodistribution and pharmacokinetics of 188Re-HEDP.

Results

3 pts were treated in the first and second cohorts, each without unacceptable toxicity.
1 of 6 pts in the highest cohort experienced unacceptable toxicity (grade 4 thrombopaenia).
MTD proved to be the maximum dose of 2500 mg/m2 per day capecitabine.
No unexpected toxicity occurred; capecitabine had no effect on uptake or excretion of 188Re-HEDP.

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