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A Study of Pemetrexed and Cyclophosphamide Given Every 21 Days in Advanced Breast Cancer Patients

NCT00190671 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2009-11-20

Study results available
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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.

Conditions

Interventions

DRUG

pemetrexed

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

DRUG

cyclophosphamide

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

DRUG

pemetrexed

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

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9am- 5pm Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • Austria
  • Czechia
  • Hungary
  • Poland
  • Romania
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00190671 on ClinicalTrials.gov