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Completed

NCT Number: NCT00190671

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pemetrexed

Drug

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

Other names: LY231514, Alimta

Cyclophosphamide

Drug

600 mg/m2, intravenous (IV), every 21 days x 8 cycles

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
Nov 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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