Conditions

Colorectal Cancer Colorectal Carcinoma Colorectal Tumor

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Progression-Free Survival (PFS) at 6 Months (PFS Rate)
PFS was defined as the time from the date of study enrollment to the first date of progressive disease or death from any cause. For participants not known to have died as of the data cut-off date and who did not have progressive disease, PFS was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy. The PFS probability values were multiplied by 100 to obtain the percentage values.
At 6 months from randomization

Secondary Outcomes (5)

Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Tumor Response Rate)
Baseline to measured progressive disease up to 13.2 months
Duration of Response
Time of response to progressive disease up to 13.2 months
Overall Survival (OS)
Randomization to date of death from any cause up to 21.9 months
Percentage of Participants With a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate)
Baseline to disease progression (up to 13.2 months)
Number of Participants With Adverse Events (AEs) or Who Died
Baseline to study completion (Cycle 31.5 [21 days/cycle] and 30-day safety follow-up)

Study Arms (2)

enzastaurin + irinotecan + cetuximab

EXPERIMENTAL

Drug: enzastaurinDrug: irinotecanDrug: cetuximab

irinotecan + cetuximab

ACTIVE COMPARATOR

Drug: irinotecanDrug: cetuximab

Interventions

enzastaurinDRUG

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

Also known as: LY317615

enzastaurin + irinotecan + cetuximab

irinotecanDRUG

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

enzastaurin + irinotecan + cetuximabirinotecan + cetuximab

cetuximabDRUG

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

enzastaurin + irinotecan + cetuximabirinotecan + cetuximab

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants are eligible to be included in the study only if they meet all of the following criteria:
Histologic diagnosis of colorectal cancer.
Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) performance status schedule.
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.
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.
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.

You may not qualify if:

Participants will be excluded from the study if they meet any of the following criteria:
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.
Have previously completed or withdrawn from this study or any other study investigating enzastaurin, irinotecan, or cetuximab.
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.
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.
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.

Contact the study team to confirm eligibility.