A Study of Irinotecan Plus Cetuximab With or Without Enzastaurin in Participants With Colorectal Cancer
Condition: Colorectal Cancer; Colorectal Carcinoma; Colorectal Tumor
MeSH terms: Colorectal Neoplasms
Intervention: enzastaurin; irinotecan; cetuximab
Intervention description: 1125 milligrams (mg) loading dose, then 500 mg orally, daily, of each 21-day cycle until progressive disease; 300 milligrams per square meter (mg/m^2) intravenously on Day 1 of each 21-day cycle until progressive disease; 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 MeSH terms: Irinotecan; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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.