A Study of Pemetrexed and Cyclophosphamide Given Every 21 Days in Advanced Breast Cancer Patients
- Registration Number
- NCT00190671
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 103
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pemetrexed 600 mg/m2 pemetrexed - Pemetrexed 600 mg/m2 cyclophosphamide - Pemetrexed 1800 mg/m2 cyclophosphamide - Pemetrexed 1800 mg/m2 pemetrexed -
- Primary Outcome Measures
Name Time Method Best Tumor Response 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
Name Time Method Time to Progressive Disease 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.
Progression Free Survival 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.
Pharmacokinetics - Maximum Observed Drug Concentration (Cmax) 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) Pharmacokinetics - Area Under the Curve (AUC) 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.
Pharmacokinetics - Clearance (CL) 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.
Pharmacokinetics - Volume of Distribution 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.
Pharmacokinetics - Half-Life (t½) 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.
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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
🇷🇺Saint Petersburg, Russian Federation