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

NCT ID: NCT00612586

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2011-11-30

Brief 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Enzastaurin + 5-FU/LV + Bev

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

Group Type: EXPERIMENTAL

Enzastaurin

Intervention Type: DRUG

1125 milligram (mg) loading dose, then 250 mg twice daily, oral up to 1 year (yr) or until progressive disease

Leucovorin (LV)

Intervention Type: DRUG

400 milligram per meter squared (mg/m\^2) intravenously (IV), Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

5-fluorouracil (5-FU)

Intervention Type: DRUG

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)

Bevacizumab (Bev)

Intervention Type: DRUG

5 milligram per kilogram (mg/kg) IV, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

Placebo + 5-FU/LV + Bev

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral, daily (up to 1 yr or until progressive disease)

Leucovorin (LV)

Intervention Type: DRUG

400 milligram per meter squared (mg/m\^2) intravenously (IV), Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

5-fluorouracil (5-FU)

Intervention Type: DRUG

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)

Bevacizumab (Bev)

Intervention Type: DRUG

5 milligram per kilogram (mg/kg) IV, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

Interventions

Enzastaurin

1125 milligram (mg) loading dose, then 250 mg twice daily, oral up to 1 year (yr) or until progressive disease

Intervention Type: DRUG

Placebo

oral, daily (up to 1 yr or until progressive disease)

Intervention Type: DRUG

Leucovorin (LV)

400 milligram per meter squared (mg/m\^2) intravenously (IV), Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

Intervention Type: DRUG

5-fluorouracil (5-FU)

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)

Intervention Type: DRUG

Bevacizumab (Bev)

5 milligram per kilogram (mg/kg) IV, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

Intervention Type: DRUG

Other Intervention Names

LY317615

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

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

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

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.

Memphis, Tennessee, 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.

Houston, Texas, United States

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Salt Lake City, Utah, United States

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Innsbruck, , Austria

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Krems, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Brest, , France

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Caen, , France

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Clichy, , France

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Lille, , France

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Marseille, , France

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Paris, , France

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Augsburg, , Germany

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Frankfurt, , Germany

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Heidelberg, , Germany

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Lübeck, , Germany

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Munich, , Germany

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München, , Germany

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Weiden, , Germany

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Bari, , Italy

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Bergamo, , Italy

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Florence, , Italy

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Livorno, , Italy

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Milan, , Italy

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San Juan, , Puerto Rico

Countries

United States; Austria; France; Germany; Italy; Puerto Rico

References

Wolff RA, Fuchs M, Di Bartolomeo M, Hossain AM, Stoffregen C, Nicol S, Heinemann V. A double-blind, randomized, placebo-controlled, phase 2 study of maintenance enzastaurin with 5-fluorouracil/leucovorin plus bevacizumab after first-line therapy for metastatic colorectal cancer. Cancer. 2012 Sep 1;118(17):4132-8. doi: 10.1002/cncr.26692. Epub 2011 Dec 27.

Reference Type: DERIVED

PMID: 22213153 (View on PubMed)

Other Identifiers

H6Q-MC-S064

Identifier Type: OTHER

Identifier Source: secondary_id

10534

Identifier Type: -

Identifier Source: org_study_id