A multicenter, single-arm, phase II study of ramucirumab plus FOLFIRI with 150 mg/m2 irinotecan, standard Nippon dose, as the second-line treatment for Japanese patients with metastatic colorectal cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer
PROVIDER: 2640889 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Intervention name : Ramucirumab
Dosage And administration of the intervention : Either ramucirumab DP (8 mg/kg) or placebo (a volume equivalent to that of ramucirumab DP), administered as an IV infusion over 60 (+10) minutes on Day 1 of each cycle; then a 1-hour observation period following the initial and second infusions of investigational product; followed by the FOLFIRI regimen indicated in the following bullets
Intervention name : Irinotecan (IRI)
Dosage And administration of the intervention : 180 mg/m2 administered intravenously over 90 (±10) minutes, 1 hour after the end of the infusion of investigational product (or immediately after the infusion of investigational product if no observation period is required) on Day 1 of each cycle; followed by
Intervention name : Folinic acid (FA)
Dosage And administration of the intervention : 400 mg/m2 administered intravenously over 120 (±10) minutes on Day 1 of each cycle; followed by
Intervention name : 5-Fluorouracil (5-FU)
Dosage And administration of the intervention : 400 mg/m2 bolus over 2 to 4 minutes administered intravenously immediately following completion of the FA infusion on Day 1 of each cycle; followed by 5-Fluorouracil (5-FU): 2400 mg/m2 administered intravenously over 46 to 48 hours (continuously) on Days 1 and 2 of each cycle
Control intervention name : null
| 2610580 | ecrin-mdr-crc
Project description:Intervention name : TAS-102
Dosage And administration of the intervention : TAS-102 as a starting dose of 25 mg/m2/dose BID (50 mg/m2/day) is administered orally in a 28-day cycle (2-week cycle of 5 days of treatment followed by a 2-day rest period, and then a 14-day rest period).
Control intervention name : irinotecan
INN of the control intervention : irinotecan
Dosage And administration of the control intervention : Irinotecan is administered by intravenous infusion at a dose of 150 mg/m2 over 90 minutes on day 1 and 15.
Primary outcome(s): Safety
CTCAE (ver.3.0)
Study Design: Open-label, multi-center, phase I study
| 2610898 | ecrin-mdr-crc
Project description:Intervention1: Biosimilar Bevacizumab: Dosage Form: It will be supplied in concentration of 25 mg/ml single dose vial for injection Dose: 7.5 mg/kg intravenously every 3 weeks for a total of 4 cycles. The initial dose (Cycle 1) should be delivered over 90 minutes as an intravenous infusion. If the first infusion (Cycle 1) is well tolerated, the second infusion (Cycle 2) may be administered over 60 minutes. If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes.
Control Intervention1: Innovator Bevacizumab: Dosage Form: It will be supplied in concentration of 25 mg/ml single dose vial for injection
Dose: 7.5 mg/kg intravenously every 3 weeks for a total of 4 cycles.
The initial dose (Cycle 1) should be delivered over 90 minutes as an intravenous infusion. If the first infusion (Cycle 1) is well tolerated, the second infusion (Cycle 2) may be administered over 60 minutes. If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes.
Primary outcome(s): To compare the efficacy of Biosimilar Bevacizumab versus Innovator Bevacizumab, both in Combination with CAPEOX in patients with metastatic colorectal cancer (mCRC) by assessment of best Overall Response Rate (ORR)Timepoint: All patients completed 12 week of treatment.
Study Design: Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
| 2596365 | ecrin-mdr-crc
Project description:<p>Individuals with Urea Cycle Disorders (UCD) cannot remove ammonia, a waste product, from the blood. At present there is little information on the use of sodium phenylbutyrate (Buphenyl™) in children with argininosuccinic aciduria (ASA). It is hoped that this drug may help lower ammonia and argininosuccinic acid levels in patients with ASA. Through this study we hope to learn whether the use of sodium phenylbutyrate (Buphenyl™) in patients with ASA, in addition to diet and arginine therapy, will decrease liver damage and the number of periods during which ammonia levels are high.</p> <p>The primary study objective is to determine if the treatment of ASA patients with sodium phenylbutyrate (Buphenyl™) in conjunction with lowered doses of arginine improves liver function as measured by short-term assessment of synthetic activity and the use of stable isotope tracers to assess ureagenesis and nitric oxide production.</p> <p>Twelve patients with ASA will be studied using a randomized, cross-over design. Medical records will be reviewed to confirm the diagnosis prior to enrollment. Patients will be on the each arm of the study for one week each preceded by a three day washout period. Patients will come to the Baylor College of Medicine General Clinical Research Center in Texas Children's Hospital for an inpatient hospitalization. This hospitalization is for diet control, clinical evaluation, and stable isotope infusions for measurement of in vivo rates of ureagenesis and nitric oxide production. During the washout periods Buphenyl™ or other alternative route medications, e.g., benzoate, will be discontinued and arginine will be administered at the standard therapeutic dose of 500 mg/kg/day or 10 grams/m2. </p> <p>Following randomization, subjects will be maintained on either high-dose arginine (500 mg/kg/day or 10 grams/m2) alone, or the alternative of low-dose arginine (100 mg/kg/d or 2 grams/m2) along with sodium phenylbutyrate (500 mg/kg/day or 10 grams/m2). For the second week they will be crossed over to the other arm of the study preceded by another three day washout. Previous medications and dietary protein intake (0.6 g/kg/day or current metabolic diet) will be continued during both arms of the study. The two arms may be performed as separate ten-day admissions.</p> <p>The decision to design the study with two arms, high-dose arginine and low-dose arginine/Buphenyl™, was reached after weighing several considerations. First, the current accepted practice for treatment of ASA is high-dose arginine. Based on metabolic flux studies, we have quantified the effects of this dose of arginine as compared to standard doses of Buphenyl™/phenylacetate on ureagenesis. Since the study is not designed or intended to address the independent effects of Buphenyl™ as compared to arginine alone, Buphenyl™ was added for safety reasons to accommodate loss of clearance of nitrogen by decreasing the arginine dose.</p> <p>Moreover, based on our experience with recruiting for previous versions of this study, most ASA patients with liver dysfunction are on an alternative route ammonia scavenger medication in addition to arginine. We found that this has in fact become an accepted practice.</p> <p>Hence, when considering study design from both a safety and recruitment perspective, it was most reasonable to design the study to investigate specifically the hypothesis that the production and presence of argininosuccinic acid leads to liver dysfunction. Since both low-dose arginine with Buphenyl™ and high-dose arginine alone lead to a decreased production of argininosuccinic acid, and both are currently accepted therapies in ASA and UCDs in general, the need to address their effects distinctly is not being investigated at this time.</p> <p>Sodium phenylbutyrate dosage will be 500 mg/kg/day in patients weighing less than 20kg and 10 g/m2/day in larger patients. Daily dosage will be given in equally divided doses 4 times per day. In order to ensure that the study remains double-blind to investigators, study staff and subjects, the Investigational Pharmacy Service at Texas Children's Hospital will dispense both the Buphenyl™ and arginine in powder form which is compounded into capsules or will be mixed with syrpalta (up to 5 grams will dissolve in 10cc liquid) and administered orally or through nasogastric or gastrostomy tube. No nasogastric tube should be placed or gastrostomy performed solely for the purpose of inclusion in this study. Because the reported adverse effects of sodium phenylbutyrate include gastritis, participants will be started on a standard dose of ranitidine (Zantac™), or comparable drug, during both arms of the study. </p>
| phs001305 | dbGaP
Project description:Interventions: investigational material(s)
Generic name etc : TAS-102
INN of investigational material :
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : TAS-102 as a starting dose of 25 mg/m2/dose BID (50 mg/m2/day) is administered orally in a 28-day cycle (2-week cycle of 5 days of treatment followed by a 2-day rest period, and then a 14-day rest period).
control material(s)
Generic name etc : irinotecan
INN of investigational material : irinotecan
Therapeutic category code : 424 Antineoplastic preparations extracted from plants
Dosage and Administration for Investigational material : Irinotecan is administered by intravenous infusion at a dose of 150 mg/m2 over 90 minutes on day 1 and 15.
Primary outcome(s): Safety
CTCAE (ver.3.0)
Study Design: Open-label, multi-center, phase I study
| 100929 | ecrin-mdr-crc
Project description:PURPOSE: Preclinically, cisplatin is synergistic with vinorelbine and the poly(ADP-ribose) polymerase (PARP) inhibitor veliparib, and has anti-neoplastic activity in TNBC and BRCA mutation-associated breast cancer. This phase I study assessed veliparib with cisplatin and vinorelbine. PATIENTS AND METHODS: A 3+3 dose escalation design evaluated veliparib administered BID for 14 days with cisplatin (75 mg/m2 day 1) and vinorelbine (25 mg/m2 days 1,8) every 21 days, for six to ten cycles, followed by veliparib monotherapy. Pharmacokinetics, measurement of poly(ADP-ribose) in peripheral blood mononuclear cells, and preliminary efficacy were assessed. Immunohistochemistry and gene expression profiling were performed to evaluate potential predictors of response.
2015-09-09 | GSE72795 | GEO
Project description:Interventions: A group (SOX+B-mab) TS-1 administered for 14 days followed by 7 days rest according to body surface area. L-OHP is administered intravenously in 130 mg/m2 at day 1. B-mab is administered intravenously in 7.5 mg/kg by tri-weekly.
B group (SOX+C-mab) TS-1 administered for 14 days followed by 7 days rest according to body surface area. L-OHP is administered intravenously in 130 mg/m2 at day 1. C-mab is administered intravenously in 400 mg/m2 on day 1, then 250 mg/m2 weekly thereafter. Or C-mab is administered intravenously in 500 mg/m2 by bi-weekly.
Primary outcome(s): Response rate
Study Design: Parallel Randomized
| 2622133 | ecrin-mdr-crc
Project description:Interventions: UFT is administered orally at 300mg/m2/day with 75mg/day of oral leucovorin for 21 consecutive days followed by a 7 days rest. CPT-11 150mg/m2/day is given intravenously on day 1 and 15 of each cycle. Cycles are repeated every 4 weeks, until occuring disease progression or severe toxicities.
The administration is done on the 1st day and the 15th day of each cycle. Cycles are repeated every 4 weeks, until occuring disease progression or severe toxicities.FOLFIRI consisted of CPT-11 150 mg/m2 IV over 90 minutes, LV 400 mg/m2 IV over 2 hours, and FU 400 mg/m2 IV bolus, followed by FU 2.400mg/m2 IV over a 46-hour infusion, repeated every 2 weeks. Cycles are repeated every 4 weeks, until evidence of disease progression or severe toxicities.
UFT is administered orally at 300mg/m2/day with 75mg/day of oral leucovorin for 21 consecutive day followed by a 7 days rest. CPT-11 and Bevacizumab are given intravenously on day 1 and 15 of each cycle. Bevacizumab is added dilute to 100mL with physiological salt solution and given intravenously over 90 minutes. After the tolerability of the initial administration time is confirmed, the time can be shortened to 60 minutes. After the tolerability of the second administration time is confirmed, the time can be shortened to 90 minutes. After the administration of Bevacizumab, CPT-11 150mg/m2/day is given Cycles are repeated every 4 weeks, until occurring disease progression or severe toxicities Cycles are repeated every 4 weeks, until occurring disease progression or severe toxicities.
The administration is done on the 1st day and the 15th day of each cycle. Cycles are repeated every 4 weeks, until occurring disease progression or severe toxicities. Bevacizumab is added dilute to 100mL with physiological salt solution and give
Primary outcome(s): Step1 Toxicity Step2 Progression-free survival
Study Design: Parallel Randomized
| 2616452 | ecrin-mdr-crc
Project description:For microRNA knockdown in vivo, a 15-mer LNA-antimiR oligonucleotide targeting mmu-miR-155 or an LNA control was administered to male 4-week-old C3H mice intravenously at a dose of 25 mg/kg per injection at days 1, 4 and 6 post-CVB3 infection. Samples were taken at 6 days post infection.
2012-06-06 | E-MEXP-3395 | biostudies-arrayexpress
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