EUCTR2012-003338-17-IT进行中（未招募）不适用
Phase II study of temozolomide in metastatic colorectal cancer patients resistant to standard therapies and with O6-methylguanine-DNA methyltransferase (MGMT) promoter hypermethylation - TEMECT
AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)0 个研究点目标入组 29 人开始时间: 2012年10月30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
- 入组人数
- 29
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
- •Signed and dated IRB/IEC-approved Informed Consent Histologically or cytologically confirmed metastatic colorectal adenocarcinoma (mCRC) Willing to submit unstained archived tumor issue if such tissue is available for analysis from primary surgery or subsequently Willing to undergo pretreatment biopsy Availability of cancerous lesion for biopsy that is both: 1. In a location amenable to image-guided core biopsy; Of adequate size (i.e. diameter at least 1 cm) to permit MGMT and other biomarkers evaluation in sample per investigators judgment Presence of hypermethylation of MGMT promoter evaluated on primary tumor tissue (paraffin embedded block from previous surgery or biopsy). Previous standard treatments including: 5-FU/capecitabine, oxaliplatin, irinotecan in patients with mutated KRAS; 5-FU/capecitabine, oxaliplatin, irinotecan, cetuximab and/or panitumumab in patients with wildtype KRAS. Prior bevacizumab treatment is allowed. In order to be included the patients should have received standard available therapies (at least two lines of prior therapies for metastatic disease). Patients treated with oxaliplatin in adjuvant setting should have progressed during or within six months of adjuvant therapy completion. Presence of measurable disease by conventional techniques (CT scan or MRI), according to RECIST 1.1. Progressive disease confirmed by CT scan or MRI after previous standard treatment. Patients withdrawn from standard treatment due to unacceptable toxicity may be enrolled into the study Male or female adult patients ³ 18 years of age ECOG (WHO) performance status 0-1 Estimated life expectancy of at least 3 months Adequate liver function (evaluated within 7 days of starting study treatment): - Bilirubin = upper limit of normal (ULN) (if liver metastases are present, then = 1.5 ULN is allowed) - Albumin = 3.0 g/dL - AST (SGOT), ALT (SGPT) < 2.5 ULN (if liver metastases are present, then < 5 ULN is allowed) 14. Alkaline phosphatase < 2.5 ULN (if liver or bone metastases are present, then < 5 ULN is allowed) Adequate renal function (evaluated within 7 days of starting study treatment): - Serum creatinine < 1.5 ULN Adequate hematologic status (evaluated within 7 days of starting study treatment): - ANC > 1,500 cells/mm3 - Platelet count > 100,000 cells/mm3 - Hemoglobin > 9.0 g/dL Agreement upon the use of effective contraceptive methods prior to study entry since signing of the informed consent until at least 3 months after the last study drug administration, if men and women of child producing potential Able and willing to adhere to the study visit schedule and to the other protocol requirements Capability to swallow capsules intact (without chewing, crushing, or opening).
- •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 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •Prior treatment with dacarbazine or temozolomide Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to inclusion 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 invading lamina propria)]Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication; Pregnant or breast-feeding patients. Women of childbearing potential must have a pregnancy test performed within a maximum of 7 days before start of treatment, and a negative pregnancy test result must be documented before start of treatment; Congestive heart failure > New York Heart Association (NYHA) class 2; Unstable angina (angina symptoms at rest), new-onset of angina (initiated within the last 3 months). Myocardial infarction less than 6 months before start of study medication. Arterial or venous thrombotic or embolic events such as cerebrovascular accidents (including transient ischemic attacks), or pulmonary embolism within the 6 months before start of study medication Ongoing infection > grade 2 NCI-CTCAE version 3.0; Untreated, symptomatic brain metastases Non-healing wound, ulcer, or bone fracture; Renal failure requiring hemo-or peritoneal dialysis; Treatment with antiviral drugs for HBV, HCV or HIV positivity; Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results; Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
研究者
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