Phase 2
Completed N=73
Pemetrexed Plus Gemcitabine in Metastatic Breast Cancer Patients After Receiving Taxane Therapy
Source: ClinicalTrials.gov NCT00063570 ↗Enrolled (actual)
73
Serious AEs
—
Results posted
May 2009
Primary outcomePrimary: Overall Tumor Response — 2; 0; 8; 5 participants
Summary
The purpose of the study is to determine if the two drugs can help patients feel better while causing the tumor to become smaller or disappear; evaluate the safety of giving both pemetrexed and gemcitabine in patients with advanced breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Tumor Response |
2; 0; 8; 5; 26; 10 | — |
| SECONDARY Duration of (Confirmed) Complete Response or Partial Response |
5.85; 4.17 | — |
| SECONDARY Time to Progressive Disease |
3.19; 4.01 | — |
| SECONDARY Time to Treatment Failure |
2.79; 2.56 | — |
| SECONDARY Overall Survival |
13.44; 16.20 | — |
Eligibility Criteria
Inclusion Criteria
- Must have received prior chemotherapy with Taxol (paclitaxel) or Taxotere (docetaxel).
- Less than 3 different chemotherapy treatments for metastatic disease.
- Prior treatment with hormonal and/or radiation therapy.
- Must have disease that can be measured.
- Must be able to take care of self needs for example personal hygiene
Exclusion Criteria
- Must not be pregnant or breast-feeding.
- Cancer that has spread to the brain.
- Treatment with Gemcitabine or Pemetrexed
- Unable to take folic acid or Vitamin B12
- Treatment for another cancer within the last 5 years
Data sourced from ClinicalTrials.gov (NCT00063570). 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.