Trial reportEuropean journal of nuclear medicine and molecular imaging2009
(188)Re-HEDP combined with capecitabine in hormone-refractory prostate cancer patients with bone metastases: a phase I safety and toxicity study.
Trial report in European journal of nuclear medicine and molecular imaging, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed, 35 citations in OpenAlex.
- Review
- Rhenium-188 Labeled Radiopharmaceuticals: Current Clinical Applications in Oncology and Promising Perspectives.Frontiers in medicine · 2019Review
- A phase I study of combined docetaxel and repeated high activity 186Re-HEDP in castration-resistant prostate cancer (CRPC) metastatic to bone (the TAXIUM trial).European journal of nuclear medicine and molecular imaging · 2011Article
- Multimodality therapy: bone-targeted radioisotope therapy of prostate cancer.Clinical advances in hematology & oncology : H&O · 2010Review
- Review
- Clinical utility ofWorld journal of nuclear medicineArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purpose(188)Re-HEDP is indicated for the treatment of pain in patients with painful osteoblastic bone metastases, including hormone-refractory prostate cancer patients. Efficacy may be improved by adding chemotherapy to the treatment regimen as a radiation sensitizer. The combination of (188)Re-HEDP and capecitabine (Xeloda(R)) was tested in a clinical phase I study.
methodsPatients with hormone-refractory prostate cancer were treated with capecitabine for 14 days (oral twice daily in a dose escalation regimen with steps of 1/3 of 2,500 mg/m(2) per day in cohorts of three to six patients, depending on toxicity). Two days later patients were treated with 37 MBq/kg (188)Re-HEDP as an intravenous injection. Six hours after treatment post-therapy scintigraphy was performed. Urine was collected for 8 h post-injection. Follow-up was at least 8 weeks. The primary end-point was to establish the maximum tolerable dose (MTD) of capecitabine when combined with (188)Re-HEDP. Secondary end-points included the effect of capecitabine on the biodistribution and pharmacokinetics of (188)Re-HEDP.
resultsThree patients were treated in the first and second cohorts, each without unacceptable toxicity. One of six patients in the highest cohort experienced unacceptable toxicity (grade 4 thrombopaenia). The MTD proved to be the maximum dose of 2,500 mg/m(2) per day capecitabine. No unexpected toxicity occurred. Capecitabine had no effect on uptake or excretion of (188)Re-HEDP.
conclusionCapecitabine may be safely used in combination with (188)Re-HEDP in a dose of 2,500 mg/m(2) per day and 37 MBq/kg, respectively. Efficacy will be further studied in a phase II study using these dosages.
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