?A Double-Blind, Randomized, Phase 2 Study of Enzastaurin with 5-FU/Leucovorin plus Bevacizumab as Maintainence Regimen Following First-Line Therapy for Metastatic Colorectal Cancer? - ND

Eli Lilly and Company0 个研究点目标入组 150 人开始时间: 2007年11月15日最近更新: 2012年5月29日

研究概览

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•- The histology types to be included are adenocarcinoma, mucinous adenocarcinoma, signet ring, and undifferentiated. Patient with neuroendrocrine carcinomas will be excluded.
•-Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group scale.
•- Received 6 cycles of firts line teraphywith FOLFOX o FOLFIRI, plus bevacizumab for recurrent CRC that has relapsed at least 12 months after completion of adjuvant therapy will also be included.
•- Prior radiotherapy must be completed 30 days before beginning first line therapy. Patients must have recovered from the toxix effects of the treatment prior to study enrollment.
•-No more than 4 weeks may pass betweenthe end of first line therapy and randomization.
•-Documented evidenceof tumor response of CR, PR or SD by computer tomography (CT) scan or magnetic resonance imaging (MRI)
•-Adequate organ function: bone marrow reserve, hepatic and renal
•-Estimated life expectancy of at least 12 week
•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

•- Are unable to swallow tablets
•- Are unable to discontinue use of enzyme inducing anti epileptic drug (EIAEDs) such as phenytoin, carbamazepine or phenobarbital
•- Have a prior malignancy (other than CRC or adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer), unless that prior malignancy was disgnosed and definitely treated at least 5 year previously wuth no subsequent evidence of recurrence
•- Are receiving cuncurrent sdministration of any other antitumor therapy
•- Have a serious cardiac condition
•- Have known central nervous system metastases
•- Have inadequately controlled hypertension
•- Have any prior history of hypertensive crisis or hypertensive encephalopathy
•- Have evidence of bleeding diathesis or coagulopathy

发起方