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OpenTrials
Completed

NCT Number: NCT00191984

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

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.

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Key information

Conditions

Metastatic 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., Angers, France

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Pemetrexed

Drug

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

Other names: LY231514, Alimta

Irinotecan

Drug

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

Primary outcomes

  1. Best Overall Tumor Response

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

    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 outcomes

  1. Duration of Response

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

    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.

  2. Progression-Free Survival (PFS)

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

    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.

  3. Time to Treatment Failure

    Time frame: baseline to stopping treatment (up to 2 years follow-up)

    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.

  4. Overall Survival

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

    Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Open Multicenter Phase II Study in Second-Line Metastatic Colorectal Cancer Patients: Combination of ALIMTA and Irinotecan Administered Every Two-Weeks

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
Jan 5, 2011

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.

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