Metastatic Colorectal Cancer
Conditions
Keywords
Colorectal cancer, Metastatic colorectal cancer, Treatment resistant, Chemotherapy refractory, KRAS mutation
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.
Interventions
DRUGPemetrexed
400 mg/m2 on day 1 of a 3 weeks cycle
DRUGGemcitabine
1000 mg/m2 intravenously on day 1 and 8 of a 3 weeks cycle
Sponsors
Vejle Hospital
Study design
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 translational research. * Fertile men and women (women \<2 year after last menstruation) must use efficient birth control. * Signed informed consent.
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | Assessed every 3 weeks by CT and/or MR scan and evaluated according to RECIST 1.1. Up to 12 months. |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival | Every 3 months until progression or death. Up to 12 months. |
| Overall survival | 12 months. |
Countries
Denmark
Outcome results
None listed