Browse
Submit Data
Databases
API
Help

Dataset Information

28 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

A phase I/II study of combination therapy with S-1/ CPT-11 plus Panitumumab as second line therapy in metastatic colorectal cancer patients with KRAS wild type

ABSTRACT: Interventions: Panitumumab;tri-weekly administration 9mg/kg. and CPT-11 is administered as an intravenous infusion at a dose of 150mg/m2(or 125 mg/m2)on day 1 and TS-1 is orally administered on days 1-14 of a 21-day cycle. Administration dose of TS-1 is based BSA : BSA<1.25m2, 40mg twice daily; 1.25-1.5m2, 50mg twice daily; >1.5m2, 60mg twice daily. Primary outcome(s): phase1 recommend dose of 1st cycle phase2 response rate Study Design: Single arm Non-randomized

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 2620657 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

A phase II study of Panitumumab combined with Irinotecan and S-1 as second line therapy in metastatic colorectal cancer patients with KRAS wild type

Project description:Interventions: Panitumumab;bi-weekly administration 6mg/kg. Irinitecan is administered as an intravenous infusion at a dose of 120mg/m2 on day 1 and 15. And TS-1 is orally administered on days 1-14 of a 28-day cycle. Administration dose of TS-1 is based BSA : BSA<1.25m2, 40mg twice daily; 1.25-1.5m2, 50mg twice daily; >1.5m2, 60mg twice daily. Primary outcome(s): Response rate Study Design: Single arm Non-randomized

| 2620142 | ecrin-mdr-crc

A phase I/II study of Cetuximab combined with irinotecan and S-1 as first line therapy in metastatic colorectal cancer patients with KRAS wild type

Project description:Interventions: Cetuximab; bi-weekly administration 500mg/m2. Irinitecan is administered as an intravenous infusion at a dose of 120mg/m2 on day 1 and 15. And TS-1 is orally administered on days 1-14 of a 28-day cycle. Administration dose of TS-1 is based BSA : BSA<1.25m2, 40mg twice daily; 1.25-1.5m2, 50mg twice daily; >1.5m2, 60mg twice daily. Primary outcome(s): Phase I study To evaluate feasibility Phase II study Response rate Study Design: Single arm Non-randomized

| 2619853 | ecrin-mdr-crc

Multicenter Phase II trial of Irinotecan plus S-1 with cetuximab (IRIS/Cet) in patients with EGFR positive and KRAS wild type of advanced/metastatic colorectal cancer

Project description:Interventions: Irinotecan plus S-1 with cetuximab combination therapy Cetuximab 400mg/m2 day1 and then 250mg/m2 day 8,15,22 weekly until PD, or Cetuximab 500mg/m2 day 1, 15, 29 biweekly until PD Irinotecan 100 mg/m2 day1,15, 30 biweekly until PD S-1 S-1 80mg [BSA<1.25m2] or 100mg [1.25m2<BSA<1.5m2] or 120mg [1.5m2<BSA]/body/day, day 1-14, q4weeks Primary outcome(s): Response rate Study Design: Single arm Non-randomized

| 2620325 | ecrin-mdr-crc

Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)

Project description:Interventions: Irinotecan plus S-1 (IRSI) with biweekly cetuximab combination therapy 1)Irinotecan 100 mg/m2 day1,15, 30 biweekly until PD 2)S-1 80mg [BSA<1.25m2] or 100mg [1.25m2<BSA<1.5m2] or 120mg [1.5m2<BSA]/body/day, day 1-14, q4weeks 3)Cetuximab 500mg/m2 day 1, 15, 29 biweekly until PD Primary outcome(s): Response rate Study Design: Single arm Non-randomized

| 2622245 | ecrin-mdr-crc

S-1 and CPT-11 plus ramucirumab (IRIS+Rmab) as second-line chemotherapy for patients with oxaliplatin-refractory metastatic colorectal cancer: A multicenter phase II study in Japan (N-DOCC-F-C-1701)

Project description:Interventions: Treatment by IRIS+Rmab Ramucirumab at a dose of 10mg/kg was administered as a 120-min infusion and irinotecan at a dose of 150mg/m2 by adjustment by UGT1A1 was administered as a 90-min infusion every 3 weeks. The dose of S-1 was determined according to the patient’s body surface area (BSA). Specifically, the drug was administered orally twice daily for 14 consecutive days at a dose that did not exceed 40 mg/m2 based on BSA as follows-BSA<1.25m2, 40 mg; BSA 1.25-1.5 m2, 50mg twice daily; and BSA >1.5 m2, 60 mg by adjustment of Ccr. Premedication with a 5-HT3 antagonist combined with dexamethasone (+/-) an NK-1 antagonist was recommended in patients before the administration of irinotecan. This treatment was administered until disease progression, unacceptable toxicity, withdrawal of consent, or the physician’s decision to terminate treatment. Primary outcome(s): progrssion free survival (PFS) Study Design: Single arm Non-randomized

| 2643378 | ecrin-mdr-crc

Phase 2/3 study of fluoropyrimidine and irinotecan plus bevacizumab versus trifluridine/tipiracil plus bevacizumab as second-line for metastatic colorectal cancer (TRUSTY)

Project description:Intervention name : trifluridine/tipiracil INN of the intervention : trifluridine/tipiracil Dosage And administration of the intervention : Trifluridine/tipiracil was given in a dose of 35-75 mg twice daily (after breakfast and dinner) (70-150 mg/day) from after dinner on Day 1 to after breakfast on Day 6 and from after dinner on Day 8 to after breakfast on Day 13. Treatment was given orally for 5 consecutive days followed by a 2-day rest. This treatment was repeated twice, followed by a 14-day rest. This 28-day cycle was repeated until the criteria for withdrawal of the study treatment were met. Intervention name : bevacizumab INN of the intervention : bevacizumab Dosage And administration of the intervention : Bevacizumab 5 mg/kg was given as a 30-min continuous intravenous infusion on Day 1 and Day 15. Control intervention name : fluorouracil INN of the control intervention : fluorouracil Dosage And administration of the control intervention : [Treatment with FOLFIRI + bevacizumab] Fluorouracil 400 mg/m2 was given by rapid intravenous injection on Day 1, followed by a 46-h continuous intravenous infusion of 2400 mg/m2. Each cycle was 14 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met. Control intervention name : TS-1(tegafur + gimeracil + oteracil potassium) INN of the control intervention : TS-1(tegafur + gimeracil + oteracil potassium) Dosage And administration of the control intervention : [Treatment with TS-1+ irinotecan +bevacizumab (3-week cycles) ] TS-1 is given orally in a dose of 40-60 mg twice daily (after breakfast and dinner) in accordance with body-surface area (80-120 mg/day), starting from after dinner on Day 1 to after breakfast on Day 15, followed by a 7-day rest. Each cycle was 21 days, and treatmen Primary outcome(s): efficacy Overall survival Study Design: Randomized, open-label, comparative study

| 2611617 | ecrin-mdr-crc

A Study Comparing Capecitabine Capsule 500 mg (IntasPharmaceuticals Ltd., India) To The Reference Listed Drug XelodaÂ(Capecitabine 500 mg; Roche Pharmaceuticals) In Patients Of BreastCancer Or Colorectal Cancer Under Fed Condition

Project description:Intervention1: Capecitabine Extended Release Capsule 500 mg (Intas Pharma) : Dose: 1250 mg/m2, Frequency: twice daily, Mode of Administration: orally, Duration of treatment: One week Control Intervention1: XelodaÂ (Capecitabine) film coated tablets 500 mg (Roche Pharmaceuticals) : Dose: 1250 mg/m2, Frequency: twice daily, Mode of Administration: orally, Duration of treatment: One week Primary outcome(s): AUCTimepoint: Day 07 and Day 14

| 2577537 | ecrin-mdr-crc

A Pharmacogenomics Study of TAS-102

Project description:Intervention name : TAS-102 Dosage And administration of the intervention : 35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met. Control intervention name : Placebo Dosage And administration of the control intervention : Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met. Primary outcome(s): Correlation between the relative factor and disease control rate, overall survival, or progression-free survival RECIST (ver.1.1) Study Design: Multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study

| 2610782 | ecrin-mdr-crc

Use-results survey for Lonsurf combination tablet T15 & Lonsurf combination tablet T20

Project description:Intervention name : Lonsurf combination tablet T15/T20 INN of the intervention : trifluridine + tipiracil hydrochloride Dosage And administration of the intervention : Usually, the standard doses below are defined as the initial dose (single dose) for adults according to body surface area (approximately 35 mg of Trifluridine/m2/dose). Lonsurf is administered twice daily, after breakfast and after the evening meal, for 5 consecutive days, followed by a 2-day rest. After repeating this twice, follows a 14-day rest. This is one cycle of the regimen and it shall be repeated. Study Design: Postmarketing surveillance

| 2611187 | ecrin-mdr-crc

Phase 2/3 study of fluoropyrimidine and irinotecan plus bevacizumab versus trifluridine/tipiracil plus bevacizumab as second-line for metastatic colorectal cancer (TRUSTY)

Project description:Interventions: investigational material(s) Generic name etc : trifluridine/tipiracil INN of investigational material : trifluridine/tipiracil Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Trifluridine/tipiracil was given in a dose of 35-75 mg twice daily (after breakfast and dinner) (70-150 mg/day) from after dinner on Day 1 to after breakfast on Day 6 and from after dinner on Day 8 to after breakfast on Day 13. Treatment was given orally for 5 consecutive days followed by a 2-day rest. This treatment was repeated twice, followed by a 14-day rest. This 28-day cycle was repeated until the criteria for withdrawal of the study treatment were met. Generic name etc : bevacizumab INN of investigational material : bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Bevacizumab 5 mg/kg was given as a 30-min continuous intravenous infusion on Day 1 and Day 15. control material(s) Generic name etc : fluorouracil INN of investigational material : fluorouracil Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : [Treatment with FOLFIRI + bevacizumab] Fluorouracil 400 mg/m2 was given by rapid intravenous injection on Day 1, followed by a 46-h continuous intravenous infusion of 2400 mg/m2. Each cycle was 14 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met. Generic name etc : TS-1(tegafur + gimeracil + oteracil potassium) INN of investigational material : TS-1(tegafur + gimeracil + oteracil potassium) Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : [Treatment with TS-1+ irinotecan +bevacizumab (3- Primary outcome(s): efficacy Overall survival Study Design: Randomized, open-label, comparative study

| 98099 | ecrin-mdr-crc

OmicsDI is part of the ELIXIR infrastructure

OmicsDI is an Elixir interoperability service. Learn more ›

Tweets

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