EUCTR2010-018700-90-DK进行中（未招募）不适用
En fase II undersøgelse af pemetrexed og gemcitabin til behandlingsresistente patienter med KRAS muteret metastaserende colorectal cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically verified adenocarcinoma in colon or rectum
- •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
- •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
排除标准
- •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.
研究者
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