Browse
Submit Data
Databases
API
Help

Dataset Information

29 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Phase 2a Study to Evaluate Suppression of 5-Fluorouracil -Induced Mucositis by TK112690

ABSTRACT: Patients expected to receive a 500 mg/m2 of Leucovorin by iv & 500 mg/m2 of Fluorouracil (5FU) by iv bolus for their Colorectal Cancer. The patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization at 5 hours & 11 hours post 5-FU iv bolus. This treatment cycle will continue weekly for 6 weeks. The TK112690 dose will be 45 mg/kg.

DISEASE(S): Mucositis,Colorectal Cancer

PROVIDER: 3838 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

Chemotherapy with Camptothecin-11 (CPT-11), Fluorouracil (5FU), folinic acid and oxaliplatin in patients with metastatic colorectal cancer

Project description:Interventions: CPT-11+ Folinic Acid+ 5FU weekly for 6 weeks on days 1,8,15,22,29 and 36 (followed by 2 weeks rest for a total cycle duration of 8 weeks) at the following doses: CPT-11: 80 mg/m2 in 250 ml normal saline intravenous injection (IV) over 90 minutes Folinic acid: 200 mg/m2 in 500 ml normal saline IV over 2 hours 5FU: 450 mg/m2 IV bolus. This 8-week cycle will be administered in an identical manner again (i.e. total 16 weeks). Then, it will be followed by Oxaliplatin+ Folinic Acid+ 5FU weekly for 6 weeks on days 1,8,15,22,29 and 36 (followed by 2 weeks rest for a total cycle duration of 8 weeks) at the following doses: Oxaliplatin: 45 mg/m2 IV over a 90 min infusion Folinic acid: 200 mg/m2 in 500 ml normal saline IV over 2 hours 5FU: 450 mg/m2 IV bolus This 8-week cycle will be administered in an identical manner again (i.e. total 16 weeks). The overall duration of the intervention will be 32 weeks in total (4 cycles). Primary outcome(s): Objective Response Rate (ORR). The ORR will be assessed by imaging methods including computed tomography (CT) scan, bone scan, X-ray etc.[At 32 months from study initiation] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial

| 2454913 | ecrin-mdr-crc

A clinical study to access safety and efficacy of TK-90 or parenteral TK-90 placebo in patients with colorectal cancer scheduled to receive bolus 5-fluorouracil and infused leucovorin.

Project description:Intervention1: Parenteral TK-90: Administered as an infusion A) Background Medication: i) LV: (Hour-0) Dose of 500 mg/m2 Intravenous infusion over two hours (window period ± 30 mins). ii) 5-FU: (Hour-1) Dose of 500 mg/m2 Intravenous bolus (window period ± 10 mins). B) TK-90 Infusion: i) First Dose: (Hour-5) Dose of 45mg/kg IV over one hour (window period ± 15 mins). ii) Second Dose: (Hour-11) Dose of 45mg/kg IV over one hour (window period ± 15 mins). Control Intervention1: Parenteral TK-90 Placebo: Administered as an infusion A) Background Medication: i) LV: (Hour-0) Dose of 500 mg/m2 Intravenous infusion over two hours (window period ± 30 mins). ii) 5-FU: (Hour-1) Dose of 500 mg/m2 Intravenous bolus (window period ± 10 mins). B) TK-90 Placebo Infusion: i) First Dose: (Hour-5) Dose of 45mg/kg IV over one hour (window period ± 15 mins). ii) Second Dose: (Hour-11) Dose of 45mg/kg IV over one hour (window period ± 15 mins). Primary outcome(s): A) SOM (Severe Oral Mucositis) - Comparison of incidences of Grade 3 or 4 mucositis (WHO scale) in the treatment (TK-90) and TK-90 placebo groups. B) Duration of SOM - Days patients suffer Grades 3 and 4 oral mucositis measured by WHO scale from the start of treatment; number of days from the first occurrence of WHO Grade 3 or 4 OM through the first occurrence of non-severe (= Grade 2) without a subsequent instance of = Grade 3 OM. patients with complete study follow-up for severe OM who do not develop severe OM (grade 0-2) will be considered to have durations of 0 days.Timepoint: 48 Hr and 96 hr every week upto week 06 and at week 08 Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded

| 2738765 | ecrin-mdr-crc

Nordic 8 - A Phase II Trial

Project description:Nordic randomized phase II trial which evaluates whether biweekly cetuximab with alternating FOLFIRI and mFOLFOX6 is more effective than biweekly cetuximab with continuously FOLFIRI in patients with potential resectable KRAS wildtype metastatic colorectal cancer. All patients will be randomized to biweekly cetuximab 500 mg/m2 in combination with arm A) FOLFIRI (irinotecan 180 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46 hours 5FU infusion of 2400 mg/m2 every 2 weeks) or arm B) FOLFIRI alternating with FOLFOX6 (Oxaliplatin: 85 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46 hours 5FU infusion of 2400 mg/m2 every 2 weeks) . Primary objective: response rate (RECIST 1.1) in patients with with potential resectable KRAS wildtype metastatic colorectal cancer. Secondary objectives: Resection rate, PFS, OS, Quality of life, tolerability. Biomarker evaluation to measure plasma biomarkers, Tumour blocks and sequential serum and plasma will be collected to search for markers that may predict efficacy including respectability and safety.

| 2145885 | ecrin-mdr-crc

Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC

Project description:Trial design: * Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with "Hyaluronic acid-Irinotecan" or "HA-Irinotecan") regimen. * Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve. * Randomized 1:1, double-blinded, multi-centre, multi-national (Australia, Bulgaria, Poland, Serbia, Russia, Ukraine and the United Kingdom). * Dosing regimen: * Irinotecan (180 mg/m2) or HA-Irinotecan (180 mg/m2), IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan and HA-Irinotecan dose in must be reduced to 150 mg/m2). * Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan. * 5-fluorouracil (5-FU), 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion. * Repeat every 2 weeks for 8 months. * Patient accrual over approximately 12-14 months. * Monitoring to 18 months post-randomization. * 390 patients. * Progression Free Survival (PFS) primary endpoint. * Safety analysis on the initial 20 patients.

| 2101890 | ecrin-mdr-crc

A randomized controlled trial comparing resection of primary tumor plus chemotherapy with chemotherapy alone in incurable Stage IV colorectal cancer(JCOG1007, iPACS)

Project description:Interventions: A: Chemotherapy alone (mFOLFOX6 or CapeOX plus bevacizumab; mFOLFOX6: bevacizumab 5 mg/kg IV on day 1, l-leucovorin 200 mg/m2 and oxaliplatin 85 mg/m2 as a 2-hour IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 followed by 2,400 mg/m2 IV over 46 hours, repeated every 2 weeks; CapeOX: bevacizumab 7.5 mg/kg IV on day 1, l-leucovorin 130 mg/m2 on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks) B: Primary resection followed by chemotherapy (mFOLFOX6 or CapeOX plus bevacizumab; mFOLFOX6: bevacizumab 5 mg/kg IV on day 1, l-leucovorin 200 mg/m2 and oxaliplatin 85 mg/m2 as a 2-hour IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 followed by 2,400 mg/m2 IV over 46 hours, repeated every 2 weeks; CapeOX: bevacizumab 7.5 mg/kg IV on day 1, l-leucovorin 130 mg/m2 on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks) Primary outcome(s): Overall survival Study Design: Parallel Randomized

| 2623557 | ecrin-mdr-crc

Gene expression-based prediction of neodjuvant chemotherapy response in early breast cancer

Project description:Prospective, non-comparative Phase II multicenter trial (EXPRESSION EudraCT: 2008-006381-29) where the patients received three 3-week cycles of docetaxel (100 mg/m2) followed by three 3-week cycles of 5-fluorouracil (500 mg/m2), epirubicin (100 mg/m2), and cyclophosphamide (500 mg/m2) (FEC). The primary end point was the identification of a gene expression signature predictive of pathological complete response (pCR). In this trial, pCR was defined as absence of invasive or non-invasive cancer in the breast. External validation of the predictive performance was performed using publicly available data.

2020-11-15 | GSE140494 | GEO

Efficacy exploration of 2nd line in advanced colorectal cancer

Project description:Interventions: Drug : Registry study Day 1. Aflibercept + FOLFIRI • aflibercept(Zaltrap): 4 mg/kg IV infusion for over 1hr (Do not administer as an IV push or bolus) • Leucovorin: 400 mg/m2 IV infusion for over 2 hours • Irinotecan: 150 mg/m2 IV infusion for over 1 hours • 5-FU: 400 mg/m2 IV bolus injection for over 5 minute • 5-FU: 2400 mg/m2IV continuous infusion for 46 hours every 2 weeks until progression disease or death or unacceptable toxicity 17 potential protein biomarkers, including cytokines and angiogenic factors, is chosen for analysis based on their roles in tumor progression: HGF, PIGF, VEGF-A, VEGF-C, VEGF-D, INF-r, IL-6, IL-8, Angiopoietin-2, sNeuropillin-1, TSP-2, OPN, sVEGFR1,2,3, sICAM-1, sVCAM-1, and TIMP-1 - Plasma is collected at baseline (Cycle 1) and cycle 4 - Plasma levels of the potential biomarkers are determined by enzyme-linked immunosorbent assays Primary outcome(s): Profression free survival

| 2512693 | ecrin-mdr-crc

JCOG2004: Randomized Phase II Study of Bevacizumab plus FOLFIRI versus Ramucirumab plus FOLFIRI versus Aflibercept plus FOLFIRI for Metastatic Colorectal Cancer after failure of First-line chemotherapy with Fluoropyrimidine and Oxaliplatin to Explore Predictive Biomarker

Project description:Interventions: Arm A: Bevacizumab+FOLFIRI (1) BEV 5 mg/kg iv (over 10 minutes) day 1 (2) l-LV 200 mg/m2 iv (2hr) day 1 (3) IRI 150 mg/m2 iv (90min) day 1 (4) 5-FU 400 mg/m2 bolus day 1 (5) 5-FU 2,400 mg/m2/46h continuous iv day 1-3 Arm B: Ramucirumab+FOLFIRI (1) RAM 8 mg/kg iv (1hr) day 1 (2) l-LV 200 mg/m2 iv (2hr) day 1 (3) IRI 150 mg/m2 iv (90min) day 1 (4) 5-FU 400 mg/m2 bolus day 1 (5) 5-FU 2,400 mg/m2/46h continuous iv day 1-3 Arm C: Aflibercept+FOLFIRI (1) AFL 4 mg/kg iv (1hr) day 1 (2) l-LV 200 mg/m2 iv (2hr) day 1 (3) IRI 150 mg/m2 iv (90min) day 1 (4) 5-FU 400 mg/m2 bolus day 1 (5) 5-FU 2,400 mg/m2/46h continuous iv day 1-3 Primary outcome(s): Progression-free survival Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

| 2739106 | ecrin-mdr-crc

Multicenter Phase II Study of FOLFIRI and biweekly Cetuximab combination chemotherapy as First Line Therapy in Patients with Wild Type KRAS Metastatic Colorectal Cancer. ( FIRBIC )

Project description:Interventions: Cetuximab 500 mg/m2/every 2weeks (day1) CPT-11 100 or 150 mg/m2 every 2weeks (day1) l-LV 200 mg/m2/every 2weeks (day1) 5-FU/bolus 400 mg/m2/every 2weeks bolus (day1) 5-FU/infusional 2,400 mg/m2/every 2weeks (day 1-3) Primary outcome(s): Response rate Study Design: Single arm Non-randomized

| 2622241 | ecrin-mdr-crc

A randomized controlled trial comparing laparoscopic surgery with open surgery in palliative resection of primary tumor in incurable Stage IV colorectal cancer (JCOG1107)

Project description:Interventions: A: Open primary tumor resection followed by chemotherapy (mFOLFOX6 or CapeOX plus bevacizumab; mFOLFOX6: bevacizumab 5 mg/kg IV on day 1, l-leucovorin 200 mg/m2 and oxaliplatin 85 mg/m2 as a 2-hour IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 followed by 2,400 mg/m2 IV over 46 hours, repeated every 2 weeks; CapeOX: bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m2 as a 2-hour IV on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks) B: Laparoscopic primary tumor resection followed by the same chemotherapy as arm A (mFOLFOX6 or CapeOX plus bevacizumab) Primary outcome(s): Progression-free survival Study Design: Parallel Randomized

| 2625109 | 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