Phase II Study of Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations
- Histologically verified adenocarcinoma in colon or rectum
- Age >18
- 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
- Fertile men and women (women <2 year after last menstruation) must use efficient
- Signed informed consent.
- 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.