En fase II undersøgelse af pemetrexed og gemcitabin til behandlingsresistente patienter med KRAS muteret metastaserende colorectal cancer

Active, not recruiting

• Conditions: Treatment resistant metastatic colorectal cancer with KRAS mutations; MedDRA version: 13.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 13.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 13.1Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2010-018700-90-DK
• Lead Sponsor: Vejle Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-26
• Last Update Posted: 24 June 2013

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

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 (<2 years after last menstruation for women) must use effecient contraception
•Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;
•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 (<2 years after last menstruation for women) must use effecient contraception
•Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

;
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified