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

Phase 2

Completed

• Conditions: Breast Cancer; Breast Neoplasms
• Interventions: Drug: Pemetrexed; Drug: Gemcitabine

• Registration Number: NCT00063570
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-06-30
• Study First Submitted QC: 2003-06-30
• Study Start: 2003-07
• Study First Posted: 2003-07-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-01-27
• Results First Submitted QC: 2009-03-26
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-12
• Results First Posted: 2009-05-13
• Last Update Posted: 2009-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Pemetrexed	-
B	Gemcitabine	-
B	Pemetrexed	-
A	Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Overall Tumor Response	Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated	Best overall (confirmed) response recorded from start of treatment until disease progression/recurrence, start of other anti-tumor therapy/intervention, or end of trial, whichever comes first. Response must be confirmed at least 6 weeks from previous scans. Best overall response assignment depends on both measurement and confirmation criteria.

Secondary Outcome Measures

Name	Time	Method
Duration of (Confirmed) Complete Response or Partial Response	Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated	Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed CR or PR + 1)/(365.25/12).
Time to Progressive Disease	Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated	Time to progressive disease is calculated as (Date of First Disease Progression or Death Due to Disease under Study whichever Comes First - First Dose Date + 1)/(365.25/12).
Time to Treatment Failure	Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated	Time to treatment failure is calculated as (Date of First Disease Progression, Death as a Result of any Cause, or Early Discontinuation of Treatment Due to Adverse Event or Physician Perception of Lack of Efficacy or Patient and Physician Perception of Lack of Efficacy, whichever Comes First - First Dose Date + 1)/ (365.25/12)
Overall Survival	Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated	Overall survival time is calculated as (Date of Death as a Result of any Cause - First Dose Date + 1)/ (365.25/12).

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.; 🇵🇷 San Juan, Puerto Rico