Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Pemetrexed

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

1000 mg/m2 intravenously on day 1 and 8 of a 3 weeks cycle

Anders Jakobsen, DMSc

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.

Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations

Phase II Study of Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations

Vejle Hospital

Rare Diseases

Oculocerebral Syndrome With Hypopigmentation

Amino Acids

Cetuximab

Afatinib

Antineoplastic Agents, Immunological

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Afatinib 40 mg daily Cetuximab 500 mg/m2 every 2 weeks until progression

Cetuximab 500mg/m2 every 2 weeks until progression After progression: Cetuximab 500mg/m2 + Afatinib 40 mg per day until progression

Afatinib taken orally, cetuximab administered intravenously

Cetuximab + Afatinib

Helene SENELLART, Dr

Evelyne BOUCHER, Dr

Eric FRANCOIS, Dr

Emmanuelle SAMALIN SCALZI, Dr

Meher BEN ABDELGHANI, Dr

Antoine ADENIS, Pr

Christelle DE LA FOUCHARDIERE, Dr

François GHIRENGHELLI, Dr

Olivier DUBROEUCQ, Dr

Emmanuelle MITRY, Dr

Christophe BORG, Pr

Yves BOUCARN, Dr

Marion CHAUVENET, Dr

This is a multicentric, phase II and open label study.75 patients are expected to be randomized in 35 centers. The main objective is to assess the efficacy and safety of Afatinib -cetuximab combo versus cetuximab alone in treatment of patients with refractory wtKRAS metastatic colorectal cancer.

Patients who will sign the inform consent will be enrolled into one of two groups. Group A will receive Afatinib ( 40mg per day) and Cetuximab (500mg/m2)every two weeks until progression. Group B will receive Cetuximab (500mg/m2) alone every two weeks until progression and after progression,patients from group B will receive afatinib (group A treatment) until progression. The criteria for evaluation will be tumor response and progression documented by CT scan and according to RECIST criteria version 1.1.

Patient will also sign a inform consent before participating in biological study. The aim of this translational study is to collect tumor and blood sample in order to determine, the biological factors which are predictive of the response to treatment.

Dual Targeting of EGFR With Cetuximab and Afatinib to Treat Refractory wtKRAS Metastatic Colorectal Cancer

A Multicentric Randomized Phase II Trial Evaluating Dual Targeting of EGFR Using the Combination of Cetuximab and Afatinib Versus Cetuximab Alone in Patients With Chemotherapy Refractory wtKRAS Metastatic Colorectal Cancer

The progression rate is defined as percentage of patients without progression at 6 months after observation of all patients at 6 months

Overall response rate is defined as percentage of subjects with a confirmed complete or partial response as per RECIST V1.1 criteria

It is define as the time of from randomization to date of first documented progression or any cause of death

Overall and specific survival is defined from time of randomization to the date of documented death

EORTC QLQ-C30 and QLQ-CR29 are questionnaires developed to assess the quality of life of cancer patients

Safety of the study treatment will be assessed on occurrence of Adverse Events (AEs)

UNICANCER

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Lymphoma

Leukemia

Acute Disease

Neoplasms by Histologic Type

Hematologic Diseases

Disease Attributes

Lymphosarcoma

Acute Graft Versus Host Disease

The subject's T cells will be modified to those which could identify and kill the tumor cells (CD19+ cells). These CD19-CAR-T2 T cells will be infused over 10-15 minutes on days Day 1, 2 and 3 tentatively according to the response to infusion.

CD19-CAR-T2 Cells

Xin Du, Dr.

Peng Li, Dr.

Jianyu Weng, Dr.

Peilong Lai, Dr.

The purpose of this study is to evaluate the safety and efficacy of chimeric antigen receptor 19 (CD19-CAR-T2 Cells) infusions in patients with chemotherapy resistant or refractory CD19+ acute Leukemia.

Phase I Study of CD19-CAR-T2 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Acute Leukemia

CD19-CAR-T2 Cells for Relapse/Refractory CD19 Positive Acute Leukemia-a Phase I Trial

Adverse events and laboratory abnormalities (type, frequency and severity)

Overall Response Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.

Chinese Academy of Sciences

Guangdong Zhaotai InVivo Biomedicine Co. Ltd.

Guangdong Provincial People's Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations	NCT01109615	Metastatic Colo...	Pemetrexed Gemcitabine	18 Years -	Vejle Hospital
Dual Targeting of EGFR With Cetuximab and Afatinib to Treat Refractory wtKRAS Metastatic Colorectal Cancer	NCT01919879	Metastatic Colo...	Cetuximab + Afa... Cetuximab	18 Years -	UNICANCER
Phase I Study of CD19-CAR-T2 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Acute Leukemia	NCT02822326	Acute Leukemia	CD19-CAR-T2 Cel...	14 Years - 65 Years	Guangdong Provincial People's Hospital

Spots Global Cancer Trial Database for chemotherapy refractory