NCT00191984

Brief Summary

A non-randomized phase II study to determine the efficacy and safety of the combination of Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2004

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 15, 2009

Completed
Last Updated

January 5, 2011

Status Verified

January 1, 2011

Enrollment Period

2.7 years

First QC Date

September 12, 2005

Results QC Date

April 27, 2009

Last Update Submit

January 3, 2011

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Best Overall Tumor Response

    Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria.

    baseline to measured progressive disease (up to 2 years follow-up)

Secondary Outcomes (4)

  • Duration of Response

    time of response to progressive disease or death (up to 2 years follow-up)

  • Progression-Free Survival (PFS)

    baseline to measured progressive disease or death (up to 2 years follow-up)

  • Time to Treatment Failure

    baseline to stopping treatment (up to 2 years follow-up)

  • Overall Survival

    baseline to date of death from any cause (up to 2 years follow-up)

Study Arms (1)

Pemetrexed + Irinotecan

EXPERIMENTAL
Drug: pemetrexedDrug: irinotecan

Interventions

pemetrexedDRUG

400 mg/m\^2, intravenous (IV), every 14 days x 12 cycles

Also known as: LY231514, Alimta
Pemetrexed + Irinotecan
irinotecanDRUG

180 mg/m\^2, intravenous (IV), every 14 days x 12 cycles

Pemetrexed + Irinotecan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of metastatic colorectal adenocarcinoma that is not amenable to curative therapy.
  • Patient must have at least one unidimensionally measurable lesion.
  • Prior radiation therapy to less than 25% of bone marrow. Radiation must be completed at least 4 weeks prior to study enrollment.
  • Performance status 0 to 2
  • Patient must have received 1 prior course of chemotherapy (Folfox regimen) for metastatic disease

You may not qualify if:

  • Treatment with any drug within the last 30 days that has not received regulatory approval.
  • Serious systemic disorder (cardiac or pulmonary disease, active infection)
  • Documented brain metastases not amenable to surgery or unstable after radiation
  • Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
  • Presence of fluid retention that can not be controlled by drainage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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.

Angers, France

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.

Lille, France

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.

Montfermeil, France

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.

Paris, France

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.

Suresnes, France

Location

Related Publications (1)

  • Louvet C, Andre T, Gamelin E, Hebbar M, Mabro M, Bennamoun M, Rassam H, de Gramont A. Phase II Study of Biweekly Pemetrexed Plus Irinotecan as Second-Line Therapy for Metastatic Colorectal Cancer. J Oncol. 2010;2010:785934. doi: 10.1155/2010/785934. Epub 2010 Apr 8.

    PMID: 20396391RESULT

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

PemetrexedIrinotecan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicCamptothecinAlkaloids

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

June 1, 2004

Primary Completion

February 1, 2007

Study Completion

May 1, 2008

Last Updated

January 5, 2011

Results First Posted

June 15, 2009

Record last verified: 2011-01

Locations

FR(5)