Pemetrexed Plus Gemcitabine in Metastatic Breast Cancer Patients After Receiving Taxane Therapy

Lilly

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Breast Neoplasms

Treatments: Drug: Gemcitabine; Drug: Pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00063570

H3E-US-JMEO

5141

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have received prior chemotherapy with Taxol (paclitaxel) or Taxotere (docetaxel).
• Less than 3 different chemotherapy treatments for metastatic disease.
• Prior treatment with hormonal and/or radiation therapy.
• Must have disease that can be measured.
• Must be able to take care of self needs for example personal hygiene

Exclusion criteria

• Must not be pregnant or breast-feeding.
• Cancer that has spread to the brain.
• Treatment with Gemcitabine or Pemetrexed
• Unable to take folic acid or Vitamin B12
• Treatment for another cancer within the last 5 years

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Pemetrexed

Drug: Gemcitabine

Drug: Pemetrexed

Drug: Gemcitabine

B

Experimental group

Treatment:

Drug: Pemetrexed

Drug: Gemcitabine

Drug: Pemetrexed

Drug: Gemcitabine