CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
Pemetrexed +3 moredrug
Likely dose
Pemetrexed 500 mg/m² IV every 14 days or every 21 days, and/or Gemcitabine 1500 mg/m² IV every 14 days or 1000 mg/m² IV on days 1 and 8 of 21-day cycleAI-extracted
Key inclusion· 4
  • ✓Prior chemotherapy with paclitaxel (Taxol) or docetaxel (Taxotere)
  • ✓Fewer than 3 different chemotherapy regimens for metastatic disease
  • ✓Measurable disease
  • ✓Able to perform self-care activities
Key exclusion· 5
  • ✕Pregnancy or breast-feeding
  • ✕Brain metastases
  • ✕Prior treatment with gemcitabine or pemetrexed
  • ✕Unable to tolerate folic acid or vitamin B12 supplementation

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

Search/NCT00063570
NCT00063570Phase 2Completed
CompareCT.gov

Phase II Trial of Alimta (Pemetrexed) and Gemzar (Gemcitabine) in Metastatic Breast Cancer Patients Who Have Received Prior Taxane Therapy

Eli Lilly and Company·interventional·Posted Jul 1, 2003·Updated May 29, 2009

In Brief

A Phase 2 clinical trial evaluating Pemetrexed and Gemcitabine for Breast Cancer and Breast Neoplasms. Completed, enrolled 73 participants across 7 sites in 2 countries.

Detailed Summary

The purpose of the study is to determine if the two drugs can help patients feel better while causing the tumor to become smaller or disappear; evaluate the safety of giving both pemetrexed and gemcitabine in patients with advanced breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Breast Neoplasms
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 1, 2003
Enrollment StartJul 1, 2003
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 23.0 years ago

Interventions

Pemetrexeddrug

500 mg/m2, intravenous (IV), every 14 days, until disease progression

Gemcitabinedrug

1500 mg/m2, intravenous (IV), every 14 days, until disease progression

Gemcitabinedrug

1000 mg/m2, intravenous (IV), on Days 1 and 8 of 21-day cycle, until disease progression

Pemetrexeddrug

500 mg/m2, intravenous (IV), every 21 days, until disease progression