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

Lilly

Status and phase: Completed; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Drug: cyclophosphamide; Drug: pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00190671

4029

H3E-MC-JMDV

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - You must be female and at least 18 years old. - You must have been diagnosed with breast cancer. - Your pre-study lab tests are within study requirements. - You must be willing to take folic acid and vitamin B12. Exclusion Criteria: - You are pregnant or breastfeeding. - You have another illness that your doctor thinks would make you unable to participate. - You are currently taking aspirin or aspirin-like medicine and are unable to stop for a few days during each cycle of therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

103 participants in 2 patient groups

Pemetrexed 600 mg/m2

Experimental group

Treatment:

Drug: pemetrexed

Drug: cyclophosphamide

Drug: pemetrexed

Pemetrexed 1800 mg/m2

Experimental group

Treatment:

Drug: pemetrexed

Drug: cyclophosphamide

Drug: pemetrexed