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Phase II study of TS-1, CPT-11 and Bevacizumab combination chemotherapy in patients with metastatic colon cancer

ABSTRACT: Interventions: CPT-11 80 mg/m2 is administered with 90 min intravenous injection on days 1, 15 repeated every 5 weeks. TS-1 80 mg/m2/day is administered orally for 4 consecutive weeks every 6 weeks. Bevacizumab 7mg/kg is administered with 30-90 min intravenous injection on days 1, 15. Primary outcome(s): Overall response rate Study Design: Single arm Non-randomized

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 2622491 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase II study of TS-1 and CPT-11 combination chemotherapy in patients with advanced/recurrent colorectal cancer.

Project description:Interventions: CPT-11 80 mg/m2 is administered with 90 min intravenous injection on days 1, 15 repeated every 5 weeks. TS-1 80 mg/m2/day is administered orally for 3 consecutive weeks every 5 weeks. Primary outcome(s): response rate Study Design: Single arm Non-randomized

| 2622561 | ecrin-mdr-crc

Multicenter Phese II Study of SOX plus Bevacizumab Therapy with Oxaliplatin Stop-and-Go Strategy and Oral S-1 plus Bevacizumab Maintenance Therapy in Advanced Colorectal CancerC

Project description:Interventions: (1)Initial therapy : SOX+bevacizumab therapy Bev : 7.5 mg/kg (90 min) L-OHP : 130 mg/m2 (120 min) S-1 : 80 - 120 mg/day (Day1-15) (2)Maintenance therapy : S-1+bevacizumab therapy Bev : 7.5 mg/kg (90 min) S-1 : 80 - 120 mg/day (Day1-15) (3)Reintroduced therapy : SOX+bevacizumab therapy Primary outcome(s): DDC ; Duration of disease control) Study Design: Single arm Non-randomized

| 2627046 | 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

Adjuvant treatment with 5-fluorouracil and folinic acid with or without irinotecan in patients with Dukes B2 or C colon cancer.

Project description:Interventions: Camptothecin-11 (CPT – 11): 80 mg/m2 in 250 ml normal saline 0,9% over a 90 min infusion followed immediately by: Folinic acid (FA): 200 mg/m2 in 500 ml normal saline 0,9% over a 120 min infusion 5-Fluorouracil (5FU): 450 mg/m2 intravenous (IV) bolus, given 60 min after initiation of FA infusion. The regimen will be administered once weekly for 4 consecutive weeks on days 1,8,15,22 followed by a 2 – week rest period. Start next cycle on day 36, for a total of 6 treatment cycles (unless intolerable toxicity occurs, which requires discontinuation of treatment). The treatment consists of 6 treatment cycles in total. Each cycle consists of 4 weeks of treatment followed by a 2-week rest period. Primary outcome(s): Disease-free survival (DFS)[3-year DFS rate (following randomisation). This outcome is assessed by physical examination, laboratory evaluation of hematology and biochemistry, computed tomography (CT), bone scan (if indicated), endoscopy at the end of the study] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial

| 2455549 | ecrin-mdr-crc

Integrative metabolomics, proteomics and transcriptomics analysis reveals liver toxicity of mesoporous silica nanoparticles

Project description:As pharmaceutical excipients, mesoporous silica nanoparticles (MSNs) have attracted considerable concern based on potential risks to the public. The impact of MSNs on biochemical metabolism is poorly understood, and few studies have compared the effects of MSNs administered via different routes. To evaluate the hepatotoxicity of MSNs, metabolomics, proteomics and transcriptomic analyses were performed in mice after intravenous (20 mg/kg/d) or oral ad-ministration (200 mg/kg/d) of MSNs for 10 days. Intravenous injection induced significant hepatic injury based on pathological inspection and increased the levels of AST/ALT and the inflammatory factors IL-6, IL-1β and TNF-a. Omics data suggested intravenous administration of MSNs perturbed the following metabolites: succinate, hypoxanthine, GSSG, NADP+, NADPH and 6-phosphogluconic acid. In addition, increases in GPX, SOD3, G6PD, HK, and PFK at proteomic and transcriptomic levels suggested elevation of glycolysis and pentose phosphate pathway, synthesis of glutathione and nucleotides, and antioxidative pathway activity, whereas oxidative phosphorylation, TCA and mitochondrial energy metabolism were reduced. On the other hand, oral administration of MSNs disturbed inflammatory factors and metabolites of ribose-5-phosphate, 6-phosphogluconate, GSSG, and NADP+ associated with the pentose phosphate pathway, glutathione synthesis and oxidative stress albeit to a lesser extent than intravenous injection despite the administration of a ten-fold greater dose. Overall, systematic biological data suggested that intravenous injection of nanoparticles of pharmaceutical excipients substantially affected hepatic metabolism function and induced oxidative stress and inflammation, whereas oral administration exhibited milder effects compared with intravenous injection.

2022-01-06 | PXD030757 | Pride

TRUSTY

Project description:Interventions: <Fluoropyrimidine+irinotecan+bevacizumab treatment arm> Prior to enrollment, investigator or subinvestigator select one of the following scheduled regimens for each patient. 1.FOLFIRI+bevacizumab therapy Bevacizumab 5 mg/kg is given as an intravenous infusion over the course of 30 min on Day 1. After that, irinotecan 150mg/m^2 is given as an intravenous infusion over the course of at least 90 min on Day 1. At the same time, levofolinate 200mg/ m^2 is given as an infusion of the course of 2 hours on Day1. After that, fluorouracil 400 mg/ m^2 was given by rapid intravenous injection on Day 1, followed by a 46-h continuous intravenous infusion of 2400 mg/ m^2. Each cycle was 14 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met. 2. S-1+irinotecan+bevacizumab therapy with a 3-week cycle Bevacizumab 7.5 mg/kg is given as an intravenous infusion over the course of 30 min on Day 1. After that, irinotecan 150 mg/m^2 is given as an intravenous infusion over the course of at least 90 min on Day 1. S-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 treatment was repeated until the criteria for withdrawal of the study treatment were met. 3. S-1+irinotecan+bevacizumab therapy with a 4-week cycle Bevacizumab 5 mg/kg is given as an intravenous infusion over the course of 30 min on Day 1 and Day 15. After that, irinotecan 100 mg/m^2 is given as an intravenous infusion over the course of at least 90 min on Day 1 and Day 15. S-1 is given orally in a dose of 40-60 mg twice daily (after breakfast and dinner) in accordance with body-sur Primary outcome(s): Overall survival Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

| 2613990 | ecrin-mdr-crc

Biomarker analysis of neoadjuvant Doxorubicin/Cyclophosphamide followed by Ixabepilone or Paclitaxel in early-stage breast cancer

Project description:A randomized, open-label, multicenter, phase II trial (NCT00455533) enrolled previously untreated women with histologically-confirmed primary invasive breast adenocarcinoma (T2–3, N0–3, M0, tumor size ≥2.0 cm), regardless of hormone receptor or HER2 expression status. Patients received sequential neoadjuvant therapy starting with 4 cycles of AC (doxorubicin 60 mg/m2 intravenously and cyclophosphamide 600 mg/m2 intravenously) given every 3 weeks, followed by 1:1 randomization to either ixabepilone (40 mg/m2 3-hour infusion) every 3 weeks for 4 cycles, or paclitaxel (80 mg/m2 1-hour infusion) weekly for 12 weeks. Fresh tumor biopsies at screening were a mandatory prerequisite for study entry for biomarker analyses. Gene expression profiling was performed by Affymetrix GeneChip to determine if pre-specified gene models could distinguish between the clinical activity of two microtubule stabilizing agents, ixabepilone and paclitaxel.

2013-01-01 | GSE41998 | GEO

To study how safe and effective is Irinotecanin treatment of colorectal cancer patients.

Project description:Intervention1: Irinotecan injection: ?Irinotecan injection 180 mg/m2 IV over 90 min, on Day 1, Day 15, Day 29 of each cycle. Combination Drug: ?Leucovorin 200 mg/m2 IV over 2 hrs, on Day 1, Day 2, Day 15, Day 16, Day 29, and Day30 of each cycle. ?5-Fluoro Uracil bolus 400 mg/m2 IV bolus, on Day 1, Day 2, Day 15, Day 16, Day 29, and Day 30 of each cycle. ?5-Fluoro Uracil infusion 600 mg/m2 IV over 22 hrs, on Day1, Day 2, Day 15, Day 16, Day29, and Day 30 of each cycle. Control Intervention1: NIL: NIL Primary outcome(s): Overall Objective Response Rate (ORR) by RECIST criteria version 1.1Timepoint: Measured at baseline, before initiation of 3rd cycle (Day85), at the end of 6th cycle (Day240) and if required at the end of the study (1 year)

| 2572851 | ecrin-mdr-crc

FOLFIRI plus cetuximab as first-line therapy followed by cetuximab maintenance therapy in patients with RAS and BRAF wild-type unresectable metastatic colorectal cancer: a single institute study

Project description:Interventions: Experimental group:cetuximab 500 mg/m2 d1, combined with irinotecan 180 mg/m2 d1, intravenous drip 90 min d1, every 2 weeks as a cycle, record the disease control. In the maintenance phase1 group, if reach disease control (PR, CR, SD) after 6-12 cycles of treatment, according to the adverse effects of patients and per;Control group:Nil Primary outcome(s): Failure-free survival Study Design: Non randomized control

| 2687328 | ecrin-mdr-crc

Extra-tumoral analysis of GBM bearing murine brains

Project description:Young (8-12 weeks) and old (80-90 weeks) mice were engrafted with 50,000 murine GL261 cells. Extra-tumoral tissue was isolated on Day 21 post intracranial injection and sent for RNA sequencing analysis. Tissue from tumor naïve young and old mice was included as .controls

2023-09-13 | GSE214294 | GEO

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