Breast CancerPhase 2NCT00063570
Pemetrexed Plus Gemcitabine in Metastatic Breast Cancer Patients After Receiving Taxane Therapy
A Phase 2 study testing Pemetrexed and Gemcitabine in people with Breast Cancer and Breast Neoplasms, run by Eli Lilly and Company at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- What is being tested?
- Pemetrexed and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jul 2003to Jan 2008
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
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.
Aurora, Colorado
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.
Dallas, Texas
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.
Morrisville, North Carolina
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.
Philadelphia, Pennsylvania
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.
Plantation, Florida
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.
Seattle, Washington
Puerto Rico1 site
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
About this study
Official title: Phase II Trial of Alimta (Pemetrexed) and Gemzar (Gemcitabine) in Metastatic Breast Cancer Patients Who Have Received Prior Taxane Therapy
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.
- Conditions
- Breast Cancer, Breast Neoplasms
- Being tested
- Pemetrexed, Gemcitabine
- Keywords
- Cancer of Breast, Cancer of the Breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Also called LY231514, Alimta
500 mg/m2, intravenous (IV), every 14 days, until disease progression
GemcitabineDrug
Also called LY188011, Gemzar
1500 mg/m2, intravenous (IV), every 14 days, until disease progression
GemcitabineDrug
Also called LY188011, Gemzar
1000 mg/m2, intravenous (IV), on Days 1 and 8 of 21-day cycle, until disease progression
PemetrexedDrug
Also called LY231514, Alimta
500 mg/m2, intravenous (IV), every 21 days, until disease progression
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Pemetrexed; Drug: Gemcitabine |
| B | Experimental | Not described Receives: Drug: Gemcitabine; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Tumor Response
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.
Measured: 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
Secondary outcomes (4)
Duration of (Confirmed) Complete Response or Partial Response
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).
Measured: 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
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).
Measured: 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
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)
Measured: 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
Overall survival time is calculated as (Date of Death as a Result of any Cause - First Dose Date + 1)/ (365.25/12).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2003 (estimated)
- Study startJul 2003
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063570
- Sponsor's protocol ID
- 5141
- Other IDs
- H3E-US-JMEO
- Status last verified
- May 2009
- First submitted
- 30 Jun 2003
- Last updated
- 29 May 2009
- Results posted
- Yes, on ClinicalTrials.gov