Study of Enzastaurin With 5-Fluorouracil/Leucovorin (5-FU/LV) Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colon Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Enzastaurin; Placebo; Leucovorin (LV); 5-fluorouracil (5-FU); Bevacizumab (Bev)
Intervention description: 1125 milligram (mg) loading dose, then 250 mg twice daily, oral up to 1 year (yr) or until progressive disease; oral, daily (up to 1 yr or until progressive disease); 400 milligram per meter squared (mg/m^2) intravenously (IV), Day 1 of 14 day cycle (up to 1 yr or until progressive disease); 400 mg/m^2 bolus then 2400 mg/m^2 IV over 46 hours, Day 1 of 14 day cycle (up to 1 yr or until progressive disease); 5 milligram per kilogram (mg/kg) IV, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)
Intervention MeSH terms: Leucovorin; Bevacizumab; Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the addition of enzastaurin to 5-FU (5-fluorouracil)/LV (leucovorin)
      plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line
      therapy consisting of 5-FU/LV + oxaliplatin (FOLFOX) or 5-FU/LV + irinotecan (FOLFIRI), plus
      bevacizumab in patients with Metastatic Colorectal Cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic diagnosis of locally advanced or metastatic colorectal cancer (CRC) that is
             not curable. The histology types to be included are adenocarcinoma, mucinous
             adenocarcinoma, signet ring, and undifferentiated. Patients with neuroendocrine
             carcinomas will be excluded.

          -  Received 6 cycles (3 months [12 weeks]) of first-line therapy with FOLFOX or FOLFIRI,
             plus bevacizumab for metastatic CRC. Patients have received at least 5 cycles with
             bevacizumab. Patients who received 6 cycles of first-line therapy with FOLFOX or
             FOLFIRI, plus bevacizumab for recurrent CRC that has relapsed at least 12 months after
             completion of adjuvant therapy will also be included. All standard FOLFOX (FOLFIRI)
             regimens given on a biweekly schedule will be permitted; however, 21-day regimens will
             not be allowed.

          -  No more than 4 weeks may pass between the end of first-line therapy (that is, Day 14
             of Cycle 6) and randomization.

          -  Documented evidence of tumor response of complete response (CR), partial response
             (PR), or stable disease (SD) by computed tomography (CT) scan or magnetic resonance
             imaging (MRI). Confirmation of response is not required.

        Exclusion Criteria:

          -  Are unable to swallow tablets.

          -  Have received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry.

          -  Have known central nervous system metastases.

          -  Are receiving concurrent administration of any other antitumor therapy.

          -  Patients who have significant heart, liver, kidney, or psychiatric disease or have an
             active infection