Phase 2
Completed N=103
A Study of Pemetrexed and Cyclophosphamide Given Every 21 Days in Advanced Breast Cancer Patients
Source: ClinicalTrials.gov NCT00190671 ↗Enrolled (actual)
103
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Best Tumor Response — 0; 0; 8; 20 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Tumor Response |
0; 0; 8; 20; 18; 26 | — |
| SECONDARY Time to Progressive Disease |
6.56 | — |
| SECONDARY Progression Free Survival |
6.26 | — |
| SECONDARY Pharmacokinetics - Maximum Observed Drug Concentration (Cmax) |
125; 369 | — |
| SECONDARY Pharmacokinetics - Area Under the Curve (AUC) |
375; 1050 | — |
| SECONDARY Pharmacokinetics - Clearance (CL) |
45.9; 51.8 | — |
| SECONDARY Pharmacokinetics - Volume of Distribution |
7.46; 8.14; 3.58; 3.33 | — |
| SECONDARY Pharmacokinetics - Half-Life (t½) |
4.19; 3.79 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00190671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.