Browse
Submit Data
Databases
API
Help

Dataset Information

26 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Intermittent or continuous Panitumumab plus FOLFIRI for first-line treatment of patients with RAS/B-RAF wild-type metastatic colorectal cancer: a randomized phase 2 trial

ABSTRACT: Primary objectives: To investigate whether experimental intermittent treatment of Panitumumab + FOLFIRI (given until progression during treatment or cumulative toxicity) results in a Progression Free Survival on treatment (PFSOT) similar to that obtained with standard continuous treatment of Panitumumab + FOLFIRI (given until progression or cumulative toxicity). Primary endpoints: PFSot is defined as the time from randomization to the firstobjective disease progression documented in patients undergoing treatment cycle (objective disease progression during treatment free intervals are excluded) or death due to any cause, whichever occurs first.

DISEASE(S): Colorectal Adenocarcinoma,Pazienti Affetti Da Tumore Del Colon-rettometastatico Ras/braf Wild-type,Patients With Ras/b-raf Wild-type Metastatic Colorectal Cancer

PROVIDER: 2537370 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

Erbitux MEtastatic Colorectal Cancer Strategy Study

Project description:* To investigate whether cetuximab alone (given until progression or cumulative toxicity) after 8 cycles of FOLFIRI + cetuximab results in a non inferior Progression Free Survival when compared with continuous FOLFIRI + cetuximab (given until progression or cumulative toxicity). * To assess whether an improvement in the incidence of grade 3-4 hematological and non-hematological adverse events (AEs) can be achieved in the experimental arm (cetuximab alone after 8 cycles FOLFIRI + cetuximab) as compared to the continuous chemotherapy arm (FOLFIRI plus cetuximab) * To explore the possibility of using liquid biopsies for molecular profiling as well as monitoring treatment activity in mCRC pts receiving cetuximab based therapy

| 2193137 | ecrin-mdr-crc

Intermittent or Continuous Panitumumab Plus FOLFIRI for RAS/B-RAF Wild-type Metastatic Colorectal Cancer

Project description:The investigators hypothesize that intermittent first-line Panitumumab plus FOLFIRI is effective as the same regimen given continuously, in unresectable metastatic RAS and BRAF wild type colorectal cancer patients. Correlative studies on tumor and blood samples could identify potential biomarkers of efficacy and help defining personalized treatment strategy.

| 2342062 | ecrin-mdr-crc

Identification of SNP candidates associated with chemo-responsiveness in colorectal cancer patients

Project description:Response rates of 118 colorectal cancer patients to regiments were evaluated by histoculture drug response assay. Affymetrix SNP 6.0 chips were used to determine genotypes of the same colorectal cancer patients. SNPs associated with chemosensitivity to treatment regiments were identified by genome-wide association study. AV: avastin (Bevacizumab), ER: Erbitux (Cetuximab), FXA: bevacizumab + FOLFOX, FXE: Cetuximab + FOLFOX , FRA: Bevacizumab + FOLFIRI, FRE: Cetuximab + FOLFIRI; Numbers (0-100) represent responsiveness to the given drug regimens; the larger, the better responsive to given regimens

2011-03-25 | GSE21228 | GEO

Panitumumab-based Maintenance in Patients With RAS Wild-type, Metastatic Colorectal Cancer (Valentino)

Project description:Open label, randomized, multicenter, phase II study to compare the efficacy, in terms of non-inferiority of progression-free survival (PFS), of maintenance with panitumumab alone (arm B) as compared to panitumumab with 5-fluorouracil (5-FU) and leucovorin (LV) (arm A) following induction treatment with 5-fluorouracil + leucovorin+oxaliplatin (FOLFOX-4) and panitumumab in patients with RAS wild-type, metastatic colorectal cancer. The study involves an induction phase with panitumumab as 1 hour intravenous infusion at the dosage of 6 mg/kg, given every two weeks, plus FOLFOX-4 chemotherapy as standard guidelines. Before start of FOLFOX-4 plus panitumumab, at the time of enrollment, patients will be immediately randomized electronically 1:1 to one of the two maintenance arms. Induction treatment with FOLFOX-4 plus panitumumab will continue until progressive disease, unacceptable toxicity or informed consent withdrawal, or for up to 8 cycles. At the end of induction treatment, in presence of complete or partial response, or stable disease, non-progressing patients will be allocated to one of the two pre-assigned maintenance arms: A) 5-FU/LV (De Gramont regimen) plus panitumumab given at 6 mg/Kg every two weeks until progressive disease, unacceptable toxicity or informed consent withdrawal B) Panitumumab alone given at 6 mg/Kg every two weeks until progressive disease, unacceptable toxicity or informed consent withdrawal Imaging studies (thorax and abdominal CT or MRI scan) will be performed at baseline (4 weeks prior enrollment) and every 8 weeks (4 cycles) during treatment.

| 2192462 | ecrin-mdr-crc

A Phase II trial of Panitumumab with irinotecan/S-1(IRIS) as 1st-line chemotherapy for KRAS wild type metastatic colorectal cancer

Project description:Interventions: Panitumumab with irinotecan/S-1(IRIS) S-1,80-120mg/body for twice daily 14 consecutive days followed by 2 weeks rest combined with intravenous CPT-11 100mg/m^2 and P-mab 6mg/kg(weight) given on day1,15 every 4 weeks until disease progression or unmanageable toxicity. Primary outcome(s): Response rate Study Design: Single arm Non-randomized

| 2623902 | ecrin-mdr-crc

MicroRNA expression profiling identified miR-31-5p/3p as associated with time to progression in wild-type KRAS metastatic colorectal cancer treated with cetuximab but not panitumumab

Project description:The aim of our study was to investigate whether miRNAs could serve as predictive biomarkers to anti-EGFR therapy (cetuximab, panitumumab) in patients with KRAS wild-type (wt-KRAS) metastatic colorectal cancer (mCRC). In our study, historical cohort of 96 patiens with wt-KRAS mCRC (2006-2009) was included and further divided into exploratory and validation cohorts. Large-scale miRNAs expression profiling was performed on the exploratory cohort of 41 wt-KRAS mCRC patients treated with cetuximab to identify miRNAs associated with time to progression (TTP). The validation was performed on two independent cohorts: 30 patients of wt-KRAS mCRC treated with cetuximab and 25 patients of wt-KRAS mCRC treated with panitumumab.

2016-05-05 | E-MTAB-3548 | biostudies-arrayexpress

A prospective study of investigating the efficacy of FOLFIRI plus Aflibercept as a 2nd line therapy after progression during FOLFOXIRI plus Bevacizumab in unrescetable / metastatic colorectal cancer (CRC) patients.

Project description:Interventions: Patients receive aflibercept (4 mg/kg) every 2 weeks on day 1 of each cycle followed immediately by FOLFIRI. Treatment continues until disease progression, unacceptable toxicity, death, patient refusal, or investigator decision. Primary outcome(s): Progression free survival Study Design: single arm study, open(masking not used), no treatment control/standard of care control, single assignment, treatment purpose

| 2615831 | ecrin-mdr-crc

A Study of FOLFIRI Plus OMP-21M18 as 1st or 2nd-line Treatment in Subjects With Metastatic Colorectal Cancer

Project description:The purpose of this study is to test the safety and determine the optimal dose of a new drug, OMP-21M18, when given in combination with FOLFIRI, a standard drug treatment for advanced colorectal cancer. Participants must not have had more than one chemotherapy regimen for their metastatic disease. OMP-21M18 is a humanized monoclonal antibody (a protein made in the laboratory) developed to target cancer stem cells. The way the body handles OMP-21M18 will also be investigated. Up to 32 participants, 21 years or older, at up to 6 centres in Australia and New Zealand, will receive intravenous infusions of OMP-21M18 followed by FOLFIRI every two weeks, until disease progression or limited by drug toxicity. After 8 weeks, participants will undergo assessments to determine their disease status. If there is no evidence of disease progression participants will continue to receive infusions of OMP-21M18 and FOLFIRI every second week, until disease progression.

| 2094190 | ecrin-mdr-crc

Evaluation for effects on anticancer efficacy and patient’s QOL from dosage adjustment caused by skin toxicity in Panitumumab treatment for Metastatic Colorectal Cancer

Project description:Interventions: mFOLFOX6+Panitumumab therapy is performed until PD. And dosage of Panitumumab is adjusted according to skin toxicity measured by self-check sheet before each therapy. Oxaliplatin 85mg/m2 5FU 400mg/m2 bolus, 2400mg/m2 continuous drip Levofolinate 200mg/m2 Panitumumab 6mg/kg Primary outcome(s): Progression-free survival Study Design: Single arm Non-randomized

| 2630399 | ecrin-mdr-crc

Phase II study of panitumumab with FOLFOX or FOLFIRI as 1st line treatment in patients with metastatic colorectal cancer in Japan

Project description:Interventions: The investigators choose the treatment A or Barbitrarily. A: FOLFOX + panitumumab B: FOLFIRI + panitumumab Repeat every 14 days until meeting the withdrawal criteria. Primary outcome(s): Overall response rate (ORR) Study Design: Single arm Non-randomized

| 2620434 | ecrin-mdr-crc

OmicsDI is part of the ELIXIR infrastructure

OmicsDI is an Elixir interoperability service. Learn more ›

OmicsDI Databases

PRIDE
PeptideAtlas
MassIVE
JPOST Repository
Physiome Model Repository

EGA
EVA
ENA
LINCS
PAXDB
Cell Collective

MetaboLights
Metabolomics Workbench
MetabolomeExpress
GNPS
BioModels
FAIRDOMHub

ArrayExpress
dbGaP
ExpressionAtlas
GEO
NODE

Information

Databases
Help
API
Contact us
Code on GitHub
Terms of use
Submit Data