CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
pemetrexed +1 moredrug
Likely dose
Pemetrexed 400 mg/m² IV + irinotecan 180 mg/m² IV, every 14 days for 12 cyclesAI-extracted
Key inclusion· 5
  • ✓Metastatic colorectal adenocarcinoma not amenable to curative therapy
  • ✓At least one unidimensionally measurable lesion
  • ✓Prior radiation to <25% of bone marrow, completed ≥4 weeks before enrollment
  • ✓ECOG performance status 0–2
Key exclusion· 5
  • ✕Treatment with unapproved drugs within 30 days
  • ✕Serious cardiac or pulmonary disease, or active infection
  • ✕Brain metastases not amenable to surgery or unstable after radiation
  • ✕Unable or unwilling to take folic acid or Vitamin B12 supplementation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00191984
NCT00191984Phase 2Completed
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted Sep 19, 2005·Updated Jan 5, 2011

In Brief

A Phase 2 clinical trial evaluating pemetrexed and irinotecan for Metastatic Colorectal Cancer. Completed, enrolled 46 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesFrance
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartJun 1, 2004
Primary CompletionFeb 1, 2007
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 20.8 years ago

Interventions

pemetrexeddrug

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

irinotecandrug

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