A Study of Irinotecan Plus Cetuximab With or Without Enzastaurin in Participants With Colorectal Cancer

NCT ID: NCT00437268

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-05-31

Brief Summary

To see how well enzastaurin in combination with irinotecan and cetuximab works versus irinotecan and cetuximab in participants who have progressed within 3 months.

Conditions

Colorectal Cancer; Colorectal Carcinoma; Colorectal Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

enzastaurin + irinotecan + cetuximab

Group Type: EXPERIMENTAL

enzastaurin

Intervention Type: DRUG

1125 milligrams (mg) loading dose, then 500 mg orally, daily, of each 21-day cycle until progressive disease

irinotecan

Intervention Type: DRUG

300 milligrams per square meter (mg/m\^2) intravenously on Day 1 of each 21-day cycle until progressive disease

cetuximab

Intervention Type: DRUG

400 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

irinotecan + cetuximab

Group Type: ACTIVE_COMPARATOR

irinotecan

Intervention Type: DRUG

300 milligrams per square meter (mg/m\^2) intravenously on Day 1 of each 21-day cycle until progressive disease

cetuximab

Intervention Type: DRUG

400 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

Interventions

enzastaurin

1125 milligrams (mg) loading dose, then 500 mg orally, daily, of each 21-day cycle until progressive disease

Intervention Type: DRUG

irinotecan

300 milligrams per square meter (mg/m\^2) intravenously on Day 1 of each 21-day cycle until progressive disease

Intervention Type: DRUG

cetuximab

400 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

Intervention Type: DRUG

Other Intervention Names

LY317615

Eligibility Criteria

Inclusion Criteria

Participants are eligible to be included in the study only if they meet all of the following criteria:

1. Histologic diagnosis of colorectal cancer.

2. Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) performance status schedule.

3. Have had documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0; Therasse et al. 2000) within 3 months after receiving 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) plus bevacizumab as first-line therapy for locally advanced or metastatic disease, or within 6 months after receiving FOLFOX with or without bevacizumab in the adjuvant setting.

4. Standard radiation therapy for rectal cancer is allowed. Participants must have recovered from the toxic effects (except for alopecia) of the treatment prior to study enrollment. Prior radiotherapy must be completed 4 weeks before study entry. Lesions that have been radiated in the advanced setting cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.

5. At least one uni-dimensionally measurable lesion meeting RECIST v1.0 guidelines (at least 10 millimeters [mm] in longest diameter by spiral computerized tomography (CT) scan, or at least 20 mm by standard techniques). Positron emission tomography (PET) scans and ultrasounds may not be used.

Exclusion Criteria

Participants will be excluded from the study if they meet any of the following criteria:

1. Have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry.

2. Have previously completed or withdrawn from this study or any other study investigating enzastaurin, irinotecan, or cetuximab.

3. Have a serious concomitant systemic disorder [such as active infection including human immunodeficiency virus (HIV), or cardiac disease] that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol.

4. Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.

5. Have a prior malignancy (other than colorectal cancer, or adequately treated carcinoma in-situ of the cervix or nonmelanoma skin cancer), unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Participants with a history of low grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours,EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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, Arizona, United States

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.

Tucson, Arizona, United States

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.

Los Angeles, California, United States

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.

Palm Springs, California, United States

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Washington D.C., District of Columbia, United States

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Orlando, Florida, United States

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Atlanta, Georgia, United States

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Arlington Heights, Illinois, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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Shreveport, Louisiana, United States

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.

Baltimore, Maryland, United States

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.

Detroit, Michigan, United States

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Kalamazoo, Michigan, United States

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.

Robbinsdale, Minnesota, United States

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.

Omaha, Nebraska, United States

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.

Valhalla, New York, United States

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.

Fort Worth, Texas, United States

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Lubbock, Texas, United States

Countries

United States

Other Identifiers

H6Q-MC-S018

Identifier Type: OTHER

Identifier Source: secondary_id

10538

Identifier Type: -

Identifier Source: org_study_id