Phase II Study of Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations

Vejle Hospital1 site in 1 country40 target enrollmentApril 2010

ConditionsMetastatic Colorectal Cancer

InterventionsPemetrexed Gemcitabine

DrugsPemetrexed Gemcitabine

Overview

Phase: Phase 2
Intervention: Pemetrexed
Conditions: Metastatic Colorectal Cancer
Sponsor: Vejle Hospital
Enrollment: 40
Locations: 1
Primary Endpoint: Response rate
Status: Terminated
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to investigate the efficacy and safety of the combination of pemetrexed and gemcitabine in heavily pre-treated, chemotherapy resistant colorectal cancer patients with KRAS mutations.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

March 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Vejle Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically verified adenocarcinoma in colon or rectum
•Metastatic colorectal cancer progressed after chemotherapy regimens containing fluoropyrimidines, oxaliplatin and irinotecan.
•KRAS mutation in primary tumour or metastasis.
•Measurable disease according to RECIST
•ECOG performance status 0, 1 or 2
•Adequate function of liver, kidneys and bone marrow measured by biochemistry (max. 2 weeks before enrolment)
•EDTA clearance: Uncorrected GFR \> 45 ml/min.
•Neutrophilocytes ≥1.5 x 10\^9/l, leukocytes ≥3.0 x 10\^9/l, thrombocytes ≥100x10\^9/l
•ALAT ≤ 3 x upper normal value (ULN), bilirubin ≤ 3 x upper normal value, Aptt and INR normal (or 2-3 at AC treatment). (ALAT and basic phosphatase ≤ 5 x upper normal value in case of liver metastases).
•Blood samples and paraffin embedded tissue from primary tumour and/or metastases for translational research.

Exclusion Criteria

•Clinically significant other concurrent disease making the patient unfit for participation in the study according to the investigator.
•Other malignant disease within 5 years prior to study enrolment, except from planocellular and basal cell carcinomas in the skin or carcinoma-in-situ cervix.
•Other experimental treatment within 30 days prior to treatment start.
•Pregnant or breastfeeding women.
•Clinical or radiological signs of CNS metastases.
•Planned radiation of target lesions.
•Concurrent vaccination against yellow fever.