A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191984
First received: September 12, 2005
Last updated: January 3, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: pemetrexed
Drug: irinotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Multicenter Phase II Study in Second-Line Metastatic Colorectal Cancer Patients: Combination of ALIMTA and Irinotecan Administered Every Two-Weeks

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Best Overall Tumor Response [ Time Frame: baseline to measured progressive disease (up to 2 years follow-up) ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Duration of Response [ Time Frame: time of response to progressive disease or death (up to 2 years follow-up) ] [ Designated as safety issue: No ]

    The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was determined 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.


  • Progression-Free Survival (PFS) [ Time Frame: baseline to measured progressive disease or death (up to 2 years follow-up) ] [ Designated as safety issue: No ]
    Defined as the time from study enrollment to the first date of disease progression or death as a result of any cause. PFS was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed.

  • Time to Treatment Failure [ Time Frame: baseline to stopping treatment (up to 2 years follow-up) ] [ Designated as safety issue: Yes ]
    Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.

  • Overall Survival [ Time Frame: baseline to date of death from any cause (up to 2 years follow-up) ] [ Designated as safety issue: Yes ]
    Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.


Enrollment: 46
Study Start Date: June 2004
Study Completion Date: May 2008
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pemetrexed + Irinotecan Drug: pemetrexed
400 mg/m^2, intravenous (IV), every 14 days x 12 cycles
Other Names:
  • LY231514
  • Alimta
Drug: irinotecan
180 mg/m^2, intravenous (IV), every 14 days x 12 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191984

Locations
France
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
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
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
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
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
Publications:
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191984     History of Changes
Other Study ID Numbers: 8673, H3E-FP-S057
Study First Received: September 12, 2005
Results First Received: April 27, 2009
Last Updated: January 3, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Irinotecan
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014