EUCTR2011-002080-21-IT进行中（未招募）不适用
Open-label phase 2 study of dacarbazine in patients with metastatic colorectal carcinoma based on expression of O6-methylguanine-DNA-methyltransferase (MGMT) - DETECT-01
AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)0 个研究点开始时间: 2012年2月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Male or female = 18 years of age;
- •2. Eastern Cooperative Oncology Group (ECOG) performance status of = 1;
- •3. Life expectancy of at least 3 months;
- •4. Understand and voluntarily sign an informed consent form;
- •5. Histologically or cytologically confirmed metastatic colorectal adenocarcinoma;
- •6. Measurable disease (RECIST criteria v1.1) using conventional techniques (CT
- •scan or MRI);
- •7. Previous treatment including: fluoropyrimidine, oxaliplatin, irinotecan for patients
- •with mutant KRAS (as assessed in primary tumor or metastases evaluating
- •codon 12 and 13 mutations) or fluoropyrimidine, oxaliplatin, irinotecan,
- •cetuximab and/or panitumumab for patients with wild-type KRAS.
- •8. Imaging confirmed (CT/MRI) disease progression within 3 months of previous
- •standard treatment. Patients who have been withdrawn from standard treatment
- •due to unacceptable toxicity will also be allowed into the study. Patients treated
- •with oxaliplatin in an adjuvant setting should have progressed during or within 6
- •months of completion of adjuvant therapy;
- •9. Women of childbearing potential and men must agree to use adequate
- •contraception since signing of the informed consent form until at least 3 months
- •after the last study drug administration;
- •10. Adequate bone marrow, liver and renal function as assessed by the following
- •laboratory requirements conducted within 7 days of starting study treatment:
- •· Total bilirubin < 1.5 x the upper limit of normal (ULN);
- •· Alanine transaminase (ALT) and aspartate aminotransferase (AST) < 2.5 x
- •ULN (<5 x ULN for patients with liver involvement of their cancer);
- •· Serum creatinine < 1.5 x the ULN;
- •· INR/PTT < 1.5 x ULN (patients who are being therapeutically anti-coagulated
- •with an agent such as warfarin or heparin will be allowed to participate
- •provided that no prior evidence of underlying abnormality in this parameter
- •exists. Close monitoring of at least weekly evaluations will be performed until
- •INR/PTT is stable based on a measurement that is pre-dose as defined by
- •the local standard of care.);
- •· Platelet count >100000 /mm3, Hemoglobin (Hb) >9 g/dL, Absolute Neutrophil
- •Count (ANC) >1500/mm3;
- •· Alkaline phosphatase limit < 2.5 x ULN (<5 x ULN for patients with liver
- •involvement by mCRC);
- •11. Able to adhere to the study visit schedule and other protocol requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •Prior treatment with dacarbazine or temozolomide;
- •2. Previous or concurrent cancer that is distinct in primary site or histology from
- •colorectal cancer within 5 years prior to randomization EXCEPT for curatively
- •treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder
- •tumors [Ta (Non-invasive tumor),Tis (Carcinoma in situ) and T1 (Tumor invades
- •lamina propria)];
- •3. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
- •before start of study medication;
- •4. Pregnant or breast-feeding patients. Women of childbearing potential must have a
- •pregnancy test performed a maximum of 7 days before start of treatment, and a
- •negative result must be documented before start of treatment;
- •5. Congestive heart failure > New York Heart Association (NYHA) class 2;
- •6. Unstable angina (angina symptoms at rest), new-onset angina (begun within the
- •last 3 months). Myocardial infarction less than 6 months before start of study
- •medication.
- •7. Arterial or venous thrombotic or embolic events such as cerebrovascular accident
- •(including transient ischemic attacks), or pulmonary embolism within the 6 months
- •before start of study medication;
- •8. Ongoing infection > grade 2 NCI-CTC version 3.0;
- •9. Untreated, symptomatic brain metastases (brain radiologic imaging not required);
- •10. Non-healing wound, ulcer, or bone fracture;
- •11. Renal failure requiring hemo-or peritoneal dialysis;
- •12. Substance abuse, medical, psychological or social conditions that may interfere
- •with the patient’s participation in the study or evaluation of the study results;
- •13. Known hypersensitivity to any of the study drugs, study drug classes, or excipients
- •in the formulation.
- •Investigational Product Dosage and
研究者
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