Treatment resistant metastatic colorectal cancer with KRAS mutations MedDRA version: 13.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 13.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 13.1 Level: PT Classifi
Conditions
Interventions
Trade Name: Alimta
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: PEMETREXED
CAS Number: 137281-23-3
Concentration unit: mg/ml milligram(s)/millilitre
Trade Na
Sponsors
Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically verified adenocarcinoma in colon or rectum • Age >18 • Metastatic colorectal cancer progressed after chemotherapy regimens containing 5-FU, oxaliplatin and irinotecan. • KRAS mutation in primary tumor or metastasis. • Measurable disease according to RECIST • ECOG performance status 0, 1 or 2 • Adequate funcion of liver, kidneys and bone marrow (biochemistry max. 2 weeks prior to inclusion in study) - EDTA clearance: Uncorrected GFR > 45 ml/min. - Neutrofilocytes =1.5 x 10^9/l, leukocytes =3.0 x 10^9/l, thrombocytes =100 - 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 fosfatase = 5 x upper normal value at liver metastases). • Blood samples and paraffin imbedded tissue from primary tumor and/or metastases for translational research. • Fertile men and women (=65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: • Histologically verified adenocarcinoma in colon or rectum • Age >18 • Metastatic colorectal cancer progressed after chemotherapy regimens containing 5-FU, oxaliplatin and irinotecan. • KRAS mutation in primary tumor or metastasis. • Measurable disease according to RECIST • ECOG performance status 0, 1 or 2 • Adequate funcion of liver, kidneys and bone marrow (biochemistry max. 2 weeks prior to inclusion in study) - EDTA clearance: Uncorrected GFR > 45 ml/min. - Neutrofilocytes =1.5 x 10^9/l, leukocytes =3.0 x 10^9/l, thrombocytes =100 - 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 fosfatase = 5 x upper normal value at liver metastases). • Blood samples and paraffin imbedded tissue from primary tumor and/or metastases for translational research. • Fertile men and women (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Clinically significant other concurrent disease, which according to the investigator makes the patient ineligible for the study. • Other malignant disease within 5 years prior to study inclusion, excl. plano cellular og basalcelle carcinomer i huden eller carcinoma-in-situ cervix forandringer. • Anden eksperimentel behandling inden for 30 dage forud for behandlingsopstart. • Gravide og ammende kvinder. • Kliniske eller radiologiske tegn på CNS-metastaser. • Planlagt strålebehandling mod target-læsioner. • Samtidig vaccination mod gul feber. ;Exclusion criteria: • Clinically significant other concurrent disease, which according to the investigator makes the patient ineligible for the study. • Other malignant disease within 5 years prior to study inclusion, excl. plano cellular og basalcelle carcinomer i huden eller carcinoma-in-situ cervix forandringer. • Anden eksperimentel behandling inden for 30 dage forud for behandlingsopstart. • Gravide og ammende kvinder. • Kliniske eller radiologiske tegn på CNS-metastaser. • Planlagt strålebehandling mod target-læsioner. • Samtidig vaccination mod gul feber.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of combination treatment pemetrexed and gemcitabine for treatment resistant metastatic colorectal cancer with KRAS mutations.;Secondary Objective: • To investigate progression free survival in treatment with pemetrexed and gemcitabine • To investigate overall survival in treatment with pemetrexed and gemcitabine • To investigate tolerability of treatment with pemetrexed and gemcitabine • Identification of prognostic and predictive markers for treatment with pemetrexed and gemcitabine ;Primary end point(s): ;Main Objective: To investigate the effect of combination treatment pemetrexed and gemcitabine for treatment resistant metastatic colorectal cancer with KRAS mutations.;Secondary Objective: • To investigate progression free survival in treatment with pemetrexed and gemcitabine • To investigate overall survival in treatment with pemetrexed and gemcitabine • To investigate tolerability of treatment with pemetrexed and gemcitabine • Identification of prognostic and predictive markers for treatment with pemetrexed and gemcitabine ;Primary end point(s): | — |
Countries
Denmark
Contacts
Public Contact; ;
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Outcome results
None listed