EUCTR2005-002570-30-HU进行中（未招募）1 期
A multicenter, randomized double-blind placebo controlled Phase III study of the efficacy of xaliproden in preventing the neurotoxicity of oxaliplatin in first-line treatment of patients with metastatic colorectal cancer treated with oxaliplatin/5-FU/LV. - NA
Sanofi-Synthelabo Recherche0 个研究点目标入组 900 人开始时间: 2005年9月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
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
- All
入选标准
- •- Histologically or cytologically-proven metastatic cancer of the colon or rectum.
- •- Metastatic disease not curable by surgery or amenable to radiation therapy with
- •curative intent.
- •- Male or female aged =18 years.
- •- WHO Performance Status (PS) : 0 or 1.
- •- At least one unidimensionally measurable lesion with a diameter =20 mm using
- •conventional CT or MRI scans or =10 mm using spiral CT scans. If a single lesion is
- •identified as the target lesion, a histological or cytological confirmation of
- •adenocarcinoma from that lesion is required.
- •- No prior chemotherapeutic regimen for metastatic disease.
- •- Prior adjuvant chemotherapy for non-metastatic disease with 5-FU/LV, with 5-
- •FU/levamizole, with irinotecan/5-FU/LV, with capecitabine is allowed. In case of
- •prior adjuvant chemotherapy, the Disease-Free interval from end of the adjuvant
- •therapy should be greater than 6 months.
- •- Prior adjuvant chemotherapy with oxaliplatin/5-FU/LV is allowed provided the
- •progression free interval from end of adjuvant therapy is greater than 12 months.
- •- Serum creatinine =1.5 X the institution’s ULN.
- •- Have adequate organ function and be medically stable.
- •- Signed written informed consent (approved by the Ethics Committee) obtained prior to study-specific screening procedure.
- •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
- •- Any condition or past medical history that contra-indicates treatment with oxaliplatin and 5-FU, as reported in approved labeling information.
- •- Peripheral neuropathy >Grade 1 (as defined by the NCI CTCAE version 3.0).
- •- Undetectable Sensory Action Potential (SAP) of both sural nerves as shown by the
- •baseline nerve conduction studies (NCS).
- •- Concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy: Ca/Mg, carbamazepine, amitriptyline, gabapentin, phenytoin, gluthatione, alpha-lipoic acid, celecoxib, amifostine, venlaflaxine, vitamin B1 (thiamine), B6 (pyridoxine).
- •- Uncontrolled intercurrent illness: e.g. high blood pressure, unstable angina,
- •symptomatic congestive heart failure (NY Heart Association Classification III or IV),
- •serious cardiac arrhythmia, diabetes, or active infection.
- •- Presence of any symptom suggesting brain metastasis.
研究者
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