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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.


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

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.


Inclusion Criteria:



- Histologic diagnosis of locally advanced or metastatic 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 ( or
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 CR, PR, or 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

baseline to measured progressive disease

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

10534

NCT ID:

NCT00612586

Start Date:

February 2008

Completion Date:

November 2011

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

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.Memphis, Tennessee  38138
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.Bedford, Texas  76022
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.Salt Lake City, Utah  84106