Skip to main content
OpenTrials
Completed

NCT Number: NCT00612586

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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., Innsbruck, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

enzastaurin

Drug

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

Other names: LY317615

Placebo

Drug

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

Leucovorin (LV)

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)

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)

Drug

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

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: Randomization to measured progressive disease or death up to 17.2 months

    PFS was defined as the time from randomization to the first observation of disease progression or death due to any cause. Progressive disease was determined using a modified version of Response Evaluation Criteria in Solid Tumor (RECIST) Assessment and was defined as at least a 20% increase in sum of longest diameter of target lesions. Time to disease progression was censored at the date of death if death was due to other cause.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Randomization up to 22.8 months

    OS was the duration from enrollment to death due to any cause. For participants who are alive, OS is censored at the last contact.

  2. Number of Participants With Adverse Events (AEs)

    Time frame: Randomization up to 17.2 months

    A summary of serious and all other non-serious AEs is located in the Reported Adverse Event module.

  3. Overall Survival (OS) From Start of First Line Therapy

    Time frame: Start of first line therapy (approximately 3 months prior to randomization) to date of death from any cause up to 27 months post randomization

    OS was the duration from first line therapy to death due to any cause. For participants who are alive, OS is censored at the last contact.

  4. PFS From Start of First Line Therapy

    Time frame: Start of first line therapy to measured progressive disease or death up to 24 months

    PFS was defined as the time from first line therapy to the first observation of disease progression or death due to any cause. Progressive disease was determined using a modified version of RECIST Assessment and was defined as at least a 20% increase in sum of longest diameter of target lesions. Time to disease progression was censored at the date of death if death was due to other cause.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Roche Pharma AG

Registry information

Official study title

A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of Enzastaurin With 5-FU/LV Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colorectal Cancer

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Feb 11, 2008
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.