- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00072865
Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer
January 24, 2007 updated by: Eli Lilly and Company
A Phase II Study of Alimta and Carboplatin in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer
This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of determining the efficacy of the combination in tumor reduction, in patients with locally advanced or metastatic breast cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Russia
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Moscow, Russia, Russian Federation
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Saint Petersburg, Russia, Russian Federation
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer
- No prior chemotherapy for locally advanced or metastatic breast disease.
- Patient may have received prior adjuvant therapy finished greater than 1 year prior to enrollment.
- Adequate bone marrow, liver and kidney function
- RECIST criteria for disease status
Exclusion Criteria:
- Prior treatment with pemetrexed
- Pregnant or breast feeding
- Brain Metastasis
- unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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antitumor activity
|
Secondary Outcome Measures
Outcome Measure |
---|
duration of response;time to progressive disease;time to treatment failure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Study Completion
September 1, 2005
Study Registration Dates
First Submitted
November 12, 2003
First Submitted That Met QC Criteria
November 12, 2003
First Posted (Estimate)
November 13, 2003
Study Record Updates
Last Update Posted (Estimate)
January 26, 2007
Last Update Submitted That Met QC Criteria
January 24, 2007
Last Verified
January 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Neoplastic Processes
- Breast Neoplasms
- Neoplasm Metastasis
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Folic Acid Antagonists
- Carboplatin
- Pemetrexed
Other Study ID Numbers
- 7771
- H3E-MW-JMGJ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Pemetrexed
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-
Rongjie TaoNational Natural Science Foundation of ChinaUnknown
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Northwestern UniversityNational Cancer Institute (NCI)UnknownLymphoma | Brain and Central Nervous System Tumors | Metastatic CancerUnited States
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PfizerTerminatedCarcinoma, Non-Small Cell LungUnited States, Germany, Italy
-
Ain Shams UniversityUnknown
-
GlaxoSmithKlineCompletedLung Cancer, Non-Small CellDenmark, United Kingdom
-
Eli Lilly and CompanyCompletedNon-Small Cell Lung Cancer Metastatic | Nonsquamous Non-Small Cell Neoplasm of Lung | Non-Small Cell Lung Cancer Stage IIIBUnited Kingdom, Sweden
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Norwegian University of Science and TechnologySt. Olavs HospitalTerminatedCarcinoma, Non-small-cell LungNorway
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University Hospital, AntwerpEli Lilly and Company; Universiteit AntwerpenCompleted