CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 103 enrolled
Drug / intervention
pemetrexed +2 moredrug
Likely dose
Pemetrexed 600 mg/m² IV plus cyclophosphamide 600 mg/m² IV every 21 days for 8 cyclesAI-extracted
Key inclusion· 4
  • ✓Female patients at least 18 years old
  • ✓Diagnosed with locally advanced or metastatic breast cancer
  • ✓Pre-study lab tests within study requirements
  • ✓Willing to take folic acid and vitamin B12 supplementation
Key exclusion· 3
  • ✕Pregnant or breastfeeding
  • ✕Concurrent illness that would prevent participation
  • ✕Unable to discontinue aspirin or NSAIDs for a few days during each treatment cycle

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

Search/NCT00190671
NCT00190671Phase 2Completed
CompareCT.gov

A Phase 1/2 Dose-Escalating Study of ALIMTA and Cyclophosphamide Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer

Eli Lilly and Company·interventional·Posted Sep 19, 2005·Updated Nov 20, 2009

In Brief

A Phase 2 clinical trial evaluating pemetrexed and cyclophosphamide for Breast Cancer. Completed, enrolled 103 participants across 13 sites in 6 countries.

Detailed Summary

This is the phase 2 portion of a phase 1/2 trial, testing the use of pemetrexed and cyclophosphamide in combination for the treatment of advanced breast cancer. A single arm Phase 1 dose finding (establish maximum tolerated dose) study precedes the randomized phase 2 portion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustria, Czechia, Hungary, Poland, Romania, Russia
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartJun 1, 2005
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.8 years ago

Interventions

pemetrexeddrug

Pemetrexed: 600 mg/m2, intravenous (IV), every 21 days x 8 cycles

cyclophosphamidedrug

600 mg/m2, intravenous (IV), every 21 days x 8 cycles

pemetrexeddrug

1800 mg/m2, intravenous (IV), every 21 days x 8 cycles