Study of Enzastaurin With 5-Fluorouracil/Leucovorin (5-FU/LV) Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colon Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: Bevacizumab (Bev); Drug: Placebo; Drug: Leucovorin (LV); Drug: 5-fluorouracil (5-FU); Drug: Enzastaurin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00612586

H6Q-MC-S064 (Other Identifier)

10534

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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117 participants in 2 patient groups, including a placebo group

Enzastaurin + 5-FU/LV + Bev

Experimental group

Description:

5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with enzastaurin

Treatment:

Drug: 5-fluorouracil (5-FU)

Drug: Enzastaurin

Drug: Leucovorin (LV)

Drug: Bevacizumab (Bev)

Placebo + 5-FU/LV + Bev

Placebo Comparator group

Description:

5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with placebo

Treatment:

Drug: 5-fluorouracil (5-FU)

Drug: Placebo

Drug: Leucovorin (LV)

Drug: Bevacizumab (Bev)