EUCTR2006-004008-38-NL进行中（未招募）不适用
The Breast CARE Study: Capecitabine (Xeloda®) combined with RHenium-188-HEDP in breast cancer patients with bone metastses; a Re-188-HEDP phase I dose escalation study and phase II efficacy study. - The Breast CARE Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Related to breast cancer:
- •Histologically documented carcinoma of the breast, resistant to both taxanes and
- •Anthracycline-containing chemotherapy regimen or resistant to taxanes and for
- •whom further Anthracycline therapy is not indicated.
- •Bone pain and/or pain medication is required for phase II testing.
- •Presence of more than one osteoblastic bone metastasis confirmed by 99mTc-labeled bisphosphonates bone scan performed within 8 weeks prior to study entry.
- •Presence of bidimensionally measurable disease as reflected by at least one
- •measurable soft tissue lesion on CT-scan performed within 4 weeks prior to study
- •Karnofsky performance status >60% (Appendix: IV).
- •Life expectancy of at least 3 months.
- •Patients with lower urinary tract obstruction or incontinence must consent to
- •catheterization of the bladder for up to 8 hours after administration of Re-188-HEDP.
- •Related to the patient:
- •Age >18 years.
- •Ability to understand and willingness to sign a written informed consent document.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Related to breast cancer:
- •1.Patients with pathologic long-bone fractures (unless surgically stabilized), imminent
- •pathologic long-bone fracture (cortical erosion on radiography > 50%), or clinical
- •evident spinal cord compression.
- •2.Patient known to have a malignancy other than breast cancer (but not including basal
- •cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix).
- •Related to previous or concomitant therapies:
- •3.Previous chemotherapy within 4 weeks prior to screening.
- •4.Any other medicine taken with the intension to treat the disease.
- •5.Use of Interferon-alpha, Allopurinol, Sorivudine and analogues and Folinic acid.
- •6.Prior treatment with a systemic radiotherapeutic bone agent (only 153Sm-EDTMP,
- •Re 186-HEDP or Re-188-HEDP) within 3 months. Prior treatment with other
- •radiotherapeutic bone agents (e.g., 89Sr-chloride, 32P -phosphate) within 6 months.
- •7.Patients receiving bisphosphonate therapy must be discontinued for at least 2 weeks
- •prior to treatment with Re-188-HEDP.
- •8.Receipt of any other investigational drug within 4 weeks of study entry.
- •9.Previous hemi-body external radiation therapy.
- •10.Receipt of external beam radiation for bone metastases with irradiation of bone
- •marrow more than 25%, within 6 months of study entry.
- •Related to the patient:
- •10.Known hypersensitivity to 5-FU, Re-188-HEDP, Capecitabine or any of the
- •excipients, or phosphate compounds.
- •11.Patients whose medical history includes clinically significant bleeding disorders which might be exacerbated by study medication.
- •12.Known deficiency of dihydropyrimidine dehydrogenase (DPD).
- •13.Patients with concurrent illnesses or treatments that might preclude study completion
- •or interfere with study results.
- •14.Patients with a history of dementia, seizures, central nervous system disorders, or
- •psychiatric disability thought to be clinically significant in the opinion of the
- •investigator and adversely affecting patient compliance with drug intake.
- •15.Patients with active CNS (grade 2 or higher) or epidural brain metastasis.
- •16.Clinical diagnosis of disseminated intravascular coagulation.
- •17.Absolute neutrophil count, ANC < 2 109/L.
- •18.Platelet count < 150 109/L.
- •19.Haemoglobin < 6 mmol/L.
- •20.Serum creatinine clearance < 50 ml/min (Cockroft and Gault).
- •21.Bilirubin > 1,5 x ULN.
- •22.SGOT/ASAT > 2.5 x ULN or SGPT/ALAT 2.5 x ULN.
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