Phase 2
Completed N=46
A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT00191984 ↗Enrolled (actual)
46
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Best Overall Tumor Response — 6; 18; 15; 5 participants
Summary
A non-randomized phase II study to determine the efficacy and safety of the combination of Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Tumor Response |
6; 18; 15; 5 | — |
| SECONDARY Duration of Response |
236 | — |
| SECONDARY Progression-Free Survival (PFS) |
123 | — |
| SECONDARY Time to Treatment Failure |
66 | — |
| SECONDARY Overall Survival |
422 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of metastatic colorectal adenocarcinoma that is not amenable to curative therapy.
- Patient must have at least one unidimensionally measurable lesion.
- Prior radiation therapy to less than 25% of bone marrow. Radiation must be completed at least 4 weeks prior to study enrollment.
- Performance status 0 to 2
- Patient must have received 1 prior course of chemotherapy (Folfox regimen) for metastatic disease
Exclusion Criteria
- Treatment with any drug within the last 30 days that has not received regulatory approval.
- Serious systemic disorder (cardiac or pulmonary disease, active infection)
- Documented brain metastases not amenable to surgery or unstable after radiation
- Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
- Presence of fluid retention that can not be controlled by drainage.
Data sourced from ClinicalTrials.gov (NCT00191984). 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.