?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
- Conditions
- Histologic diagnosis of locally advanced or metastatic colorectal that is not amenable to curative theraphy cancerMedDRA version: 9.1Level: LLTClassification code 10061451Term: Colorectal cancer
- Registration Number
- EUCTR2007-003844-31-IT
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare Arm A versus Arm B in terms of PFS measured from the time of randomization after completing 6 cycles of first-line teraphy for metastaic CRC.;Secondary Objective: To compare the following best treatment Arms:<br>- OS from the time of the randomization<br>- OS and PFS from the start of first-line teraphy.<br><br>To assess the safety and AE profile in both treatment arms using Common Terminology Criteria for Adverse Event (CTCAE Version 3.0, NCl2006).;Primary end point(s): The primary endpoint is PFS from the time of randomization
- Secondary Outcome Measures
Name Time Method