Browse
Submit Data
Databases
API
Help

Dataset Information

0 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.

ABSTRACT: This 2 arm study will assess the efficacy and safety of Avastin in combination with irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid alone, as first line treatment in Chinese patients with metastatic colorectal cancer. Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2 weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease progression, and the sample size is 100-500 individuals.

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2052695 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

A prospective study comparing targeted anticancer drug + irinotecan and targeted anticancer drug + 5-Fluorouracil / Leucovorin as maintenance treatment after primary induction chemotherapy for metastatic colorectal cancer

Project description:Interventions: Drug : This randomized phase 2 clinical trial aims to evaluate the effect of the Bevacizumab/Cetuximab+Irinotecan group compared to the Bevacizumab/Cetuximab+5-fluorouracil/Leucovorin group as maintenance therapy. Administer according to the recommended dosage regimen or the standard of the local institution Experomental group Bevacizumab or Cetuximab + Irinotecan, control group Bevacizumab or Cetuximab + 5 fluorouracil therapy every 2 weeks Recommended dose for Experomental group : Bevacizumab 5mg kg IV Day1, Cetuximab 500mg/m2 IV Day1 , Irinotecan 180mg/m2 IV Day1 Recommended dose of control group: Bevacizumab 5mg kg IV Day1, Cetuximab 500mg/m2 IV Day1,Leucovorin 400mg/m2 IV Day1, 5-fluorouracil 400mg/m2 IV bolus Day1 , 5-fluorouracil 2,400mg/m2 IV Day1-2 Primary outcome(s): Percentage of patients with progression-free status after secondary chemotherapy at one year from random assignment 1yr-PFS2 rate Primary Purpose : Treatment, Intervention Model : Parallel, Blinding/Masking : Open, Allocation : RCT

| 74818 | ecrin-mdr-crc

Phase I study of 5-FU + Oxaliplatin + Irinotecan + Levofolinate + Panitumumab as the first-line therapy in patients with KRAS or RAS wild-type metastatic colorectal cancer

Project description:Interventions: FOLFOXIRI+Panitumumab (Until 12 courses) Panitumumab 6mg/kg/bi-weekly Irinotecan 165-125mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 3200mg/m2/bi-weekly Primary outcome(s): Recommended Dose Study Design: Single arm Non-randomized

| 2630804 | ecrin-mdr-crc

Multicenter Phase II study of rechallenge Cetuximab plus Irinotecan in heavily pretreated Wild type KRAS metastatic Colorectal cancer

Project description:Interventions: Cetuximab + Irinotecan therapy Cetuximab Weekly schedule 400mg/(initial dose):250mg/m2(Maintenance dose) every week or Bi-weekly schedule 500mg/m2 every 2 weeks Irinotecan 150mg/m2 every 2 weeks Primary outcome(s): Response rate Study Design: Single arm Non-randomized

| 2625919 | ecrin-mdr-crc

A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer

Project description:This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

| 2005734 | ecrin-mdr-crc

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

Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis

Project description:Interventions: 20mg/m2 of weekly Intraperitoneal paclitaxel Primary outcome(s): Safety Study Design: Single arm Non-randomized

| 2638181 | ecrin-mdr-crc

Short Course Oncology Therapy. A study of adjuvant chemotherapy in colorectal cancer.

Project description:Interventions: Sites are able to select either oxaliplatin/5-FU (Folfox) or oxaliplatin/capecitabine (Xelox). Folfox - Oxaliplatin 85mg/m2 IV (intravenously) on day 1 concurrently with L-folinic acid 175mg or folinic acid 350mg(Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours), followed by 5-fluorouracil 400mg/m2 IV bolus injection over 5 minutes followed by 5-flourouracil 2400mg/m2 IV continuous infusion over 46 hours in 14 day cycle for 12 weeks. Treatment with combination Oxaliplatin -5 Fluorouracil (5-FU) is on days 1-3 and rest days are day 4-14. Use of L-folinic acid 175mg or folinic acid 250mg is determined by the pharmacy stock and usual practice at site. Xelox – Oxaliplatin 130mg/m2 IV on day 1 (Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours). Capecitabine 1000mg/m2 PO twice daily for 14 days for 12 weeks. Primary outcome(s): Disease free survival, determined as time from randomisation to recurrence, development of new colorectal cancer or death from any cause.[During treatment: prior to each treatment cycle. Patients on the 3 month treatment arm will be reviewed 4 weekly for the first twelve weeks after completion of chemotherapy. Clinical examination and Carcinoembryonic Antigen test will be performed at each visit. Follow-up: assessment will be at three monthly intervals until month 12 then 6 monthly until month 24 and annually thereafter.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy

| 2454988 | ecrin-mdr-crc

A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.

Project description:This single arm study will assess the efficacy and safety of a combination of modified FOLFIRI (irinotecan, 5-FU and leucovirin), Avastin and cetuximab in patients with previously untreated metastatic colorectal cancer. Patients will receive modified FOLFIRI (irinotecan 180mg/m2 iv, leucovirin 200mg/m2 iv, and 5-FU 400mg/m2 iv) on day 1 of each 2 week cycle, in combination with Avastin (5mg/kg iv on day 1 of each cycle) and cetuximab (loading dose of 400mg/m2 followed by 250mg/m2 on day 3 of each cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals.

| 2047783 | 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

Genome and transcriptome study of the response to irinotecan and bevacizumab in recurrent glioblastomas (CIT - Homo sapiens - BEVA)

Project description:A Cartes d'Identite des Tumeurs (CIT) project from the French National League Against Cancer (http://cit.ligue-cancer.net ) 25 glioblastoma multiforme tumors hybridized on Illumina SNP and Affymetrix gene expression arrays. Project leader : François DUCRAY (francois.ducray@chu-lyon.fr). CIT Analysis : Julien LAFFAIRE (laffairej@ligue-cancer.net). Note: PFS : progression-free survival, OS: Overall Survival,BCNU : Carmustine (chemotherapy agent). RESPONDER: if the patient has shown or not shown a response to the treatment (Bevacizumab (Avastin) plus Irinotecan). Progression during : If the disease has progressed (cancer relapse or patient's death); otherwise (patient is alive without relapse).

2013-01-15 | E-MTAB-951 | biostudies-arrayexpress

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