A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer

Lilly

Status and phase

Completed

Phase 2

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: pemetrexed

Drug: irinotecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191984

8673

H3E-FP-S057 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.