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

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ClinicalTrials.gov Identifier: NCT00190671
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : July 16, 2009
Last Update Posted : November 20, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: pemetrexed Drug: cyclophosphamide Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Dose-Escalating Study of ALIMTA and Cyclophosphamide Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer
Study Start Date : June 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pemetrexed 600 mg/m2 Drug: pemetrexed
Pemetrexed: 600 mg/m2, intravenous (IV), every 21 days x 8 cycles
Other Names:
  • LY231514
  • Alimta

Drug: cyclophosphamide
600 mg/m2, intravenous (IV), every 21 days x 8 cycles
Experimental: Pemetrexed 1800 mg/m2 Drug: cyclophosphamide
600 mg/m2, intravenous (IV), every 21 days x 8 cycles

Drug: pemetrexed
1800 mg/m2, intravenous (IV), every 21 days x 8 cycles
Other Names:
  • LY231514
  • Alimta


Outcome Measures
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Primary Outcome Measures :
  1. Best Tumor Response [ Time Frame: baseline to measured progressive disease ]
    Tumor response was assessed using radiological imaging, which was repeated every 6 weeks prior to every other cycle. Confirmation of response was to occur no less than 4 weeks (28 days) after the first evidence of response.


Secondary Outcome Measures :
  1. Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ]
    Time to progressive disease was defined as the time from the date of the first treatment dose to the first date of progressive disease or death from study disease.

  2. Progression Free Survival [ Time Frame: baseline to measured progressive disease ]
    Defined as date of first treatment dose to first date of progressive disease or death from any cause. For patients not known to have died as of data cutoff date and who did not have progressive disease, the progression free survival date was censored at last contact date.

  3. Pharmacokinetics - Maximum Observed Drug Concentration (Cmax) [ Time Frame: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion) ]
  4. Pharmacokinetics - Area Under the Curve (AUC) [ Time Frame: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion) ]
    Area under the gemcitabine concentration-time curve from zero to last quantifiable concentration [AUC(0-t)] was calculated by combination of linear and logarithmic trapezoidal methods. Linear trapezoidal method was employed up to tmax (time to reach maximal concentration), and then log trapezoidal method was used for those data after tmax.

  5. Pharmacokinetics - Clearance (CL) [ Time Frame: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion) ]
    Total body clearance of drug calculated after intravenous administration.

  6. Pharmacokinetics - Volume of Distribution [ Time Frame: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion) ]
    Central volume (V1) and peripheral volume (V2) of distribution.

  7. Pharmacokinetics - Half-Life (t½) [ Time Frame: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion) ]
    The half-life associated with the terminal elimination rate constant.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190671


Locations
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Austria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
Salzburg, Austria, 5020
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
Wels, Austria, 4600
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
Wien, Austria, A-1100
Czech Republic
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
Brno, Czech Republic, 625 00
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
Nova Ves Pod Plesi, Czech Republic, 26204
Hungary
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
Budapest, Hungary, 1122
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
Szeged, Hungary, 6720
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
Gdansk, Poland, 80-210
Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
Bucharest, Romania, 022328
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
Cluj-Napoca, Romania, 3400
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
Iasi, Romania, 6600
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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
Moscow, Russian Federation, 129128
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
Saint Petersburg, Russian Federation, 197022
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9am- 5pm Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00190671    
Other Study ID Numbers: 4029
H3E-MC-JMDV
First Posted: September 19, 2005    Key Record Dates
Results First Posted: July 16, 2009
Last Update Posted: November 20, 2009
Last Verified: November 2009
Keywords provided by Eli Lilly and Company:
Advanced Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Pemetrexed
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors