NL-OMON42542已完成2 期
Second-line chemotherapy FOLFIRINOX in unresectable cholangiocarcinoma - 4CC
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Histological or cytological diagnosis of cholangiocarcinoma. Histological
- •diagnosis is needed if a patient wants to participate in the translational
- •study (see section 11).
- •- Metastatic disease or unresectable locally advanced
- •cholangiocarcinoma.
- •- Measurable disease according RECIST criteria version 1.1.
- •- Age from 18 up to 75 year.
- •- ECOG performance status 0-1.
- •- Patients who received at least 3 cycles of gemcitabine/cisplatin in the
- •first-line.
- •- Adequate hematological function (WBC > 3.0 x 109/L, platelets > 100
- •- Adequate hepatic function (bilirubin * 1.5 x upper normal limit (ULN);
- •ALAT or ASAT <5x ULN in case of liver metastases and < 2.5 x ULN in
- •absence of liver metastases.
- •- Adequate renal function (creatinine clearance > 60 ml/min; creatinine
- •<120 µmol/L)
- •- Absence of cardiac insufficiency, chest pain (not medically controlled)
- •and myocardial infarction in the 12 months preceding study entry.
- •- Written informed consent.
排除标准
- •- Concurrent secondary malignancies or other malignancies within 3
- •years prior to enter this study with the exception of non-metastatic
- •basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •treated by cone-biopsy or resection
- •- Presence of cerebral or meningeal metastases
- •- Hypersensitivity to the active substance of oxaliplatin,
- •leucoverin,irinotecan and/ or 5-FU or to any of excipients used in these
- •drugs as described in Summary of Product Characteristics (SPCs).
- •- History of chronic diarrhea or colorectal inflammatory conditions
- •- Active infection or other serious underlying conditions which may
- •prevent the patient from receiving the planned treatment. For example:
- •prolonged unresolved bacterial cholangitis with destruction of bile duct
- •branches (e.g. after endoprothesis insertion) or two or more periods of
- •cholangitis in the last 6 months. Patients with other active or
- •uncontrolled severe infection, cirrhosis or chronic active hepatitis will be
- •- Presence of cardiac insufficiency, unstable angina pectoris,
- •symptomatic congestive heart, failure myocardial infarction 6 months
- •prior to randomization, serious uncontrolled cardiac arrhythmia.
- •- Patients with peripheral sensory neuropathy with functional
- •impairment prior to the first cycle of FOLFIRINOX.
- •- Bone marrow depression after radiotherapy or treatment with other
- •antineoplastic drugs, defined as baseline values neutrophils <2 x 109 / L
- •and / or platelets <100 x 109 / L.
- •- Current iInclusion in another investigational clinical trial of cancer
- •- Patients who use Azole antifungals and/or anti-cancer medication at
- •inclusion (see section 6.1.6). Patients who use brivudine, sorivudine and
- •there analogs. Patiënt with concomitant use of St. John's wort
- •preparations.
- •- Pernicious anemia or other anaemias due to vitamin B 12 deficiency.
- •- Males who wish to have children while receiving this chemotherapy or
- •within 6 months after the end of participation in this study.
- •- Women who are pregnant, breast-feeding or not using adequate
- •contraceptive
- •- Age younger than 18 or older than 75 years
- •- ECOG performance status >1.
- •- Incapacitated persons who are not able to provide consent.
研究者
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