A Study of Irinotecan Plus Cetuximab With or Without Enzastaurin in Participants With Colorectal Cancer
Part of paid clinical trials in Casa Grande, Arizona.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT00437268
- Phase
- PHASE2
- Status
- Completed
Conditions
- Colorectal Cancer
- Colorectal Carcinoma
- Colorectal Tumor
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- enzastaurin — DRUG1125 milligrams (mg) loading dose, then 500 mg orally, daily, of each 21-day cycle until progressive disease
- irinotecan — DRUG300 milligrams per square meter (mg/m\^2) intravenously on Day 1 of each 21-day cycle until progressive disease
- cetuximab — DRUG400 mg/m\^2, intravenously on Day 1, 250 mg/m\^2 on Day 8, Day 15 Cycle 1 then 250 mg/m\^2, on Day 1, 8 and 15 of each cycle, intravenously 21-day cycles until progressive disease
Study Details
To see how well enzastaurin in combination with irinotecan and cetuximab works versus irinotecan and cetuximab in participants who have progressed within 3 months.
Key Dates
- Start date
- Mar 31, 2007
- Status verified
- Jul 2020
- Primary completion
- May 31, 2009
- Completion
- May 31, 2009
Study Design
- Enrollment
- 26 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: enzastaurin + irinotecan + cetuximab
- Active Comparator: irinotecan + cetuximab
Primary Outcome Measure
Percentage of Participants With Progression-Free Survival (PFS) at 6 Months (PFS Rate) [ Time Frame: At 6 months from randomization ]
Locations (20)
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.· Casa Grande, AZFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.· Tucson, AZFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.· Los Angeles, CAFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.· Palm Springs, CAFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.· Washington D.C., DCFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.· Orlando, FL
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