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A feasibility study of Oxaliplatin(L-OHP)in combination with infusional 5-FU/l-LV(FOLFOX4 regimen)for advanced colorectal cancer

ABSTRACT: Intervention name : Oxaliplatin|Fluorouracil|Levofolinate calcium Dosage And administration of the intervention : Intravenous infusion Primary outcome(s): Safety Study Design: Open-label, multicenter trial

DISEASE(S): Colorectal Cancer

PROVIDER: 2609919 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A feasibility study of Oxaliplatin(L-OHP)in combination with infusional 5-FU/l-LV(FOLFOX4 regimen)for advanced colorectal cancer

Project description:Interventions: investigational material(s) Generic name etc : Oxaliplatin|Fluorouracil|Levofolinate calcium INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous infusion Primary outcome(s): Safety Study Design: Open-label, multicenter trial

| 99274 | ecrin-mdr-crc

Phase II/III Trial of CPT-11/5-FU/l-LV (FOLFIRI) Versus CPT-11/TS-1 (IRIS) as Second Line Chemotherapy of Unresectable Colorectal Cancer

Project description:Intervention name : Irinotecan hydrochloride | Tegafur/Gimeracil/ Oteracil Potassium | Fluorouracil | Levofolinate Calcium Dosage And administration of the intervention : Irinotecan hydrochloride : injection, Fluorouracil : injection, Levofolinate Calcium : injection, Tegafur/Gimeracil/ Oteracil Potassium capsule : oral Primary outcome(s): Progression free survival Study Design: Open label, multicenter phase 2 / 3 study

| 2609944 | ecrin-mdr-crc

Phase II/III Trial of CPT-11/5-FU/l-LV (FOLFIRI) Versus CPT-11/TS-1 (IRIS) as Second Line Chemotherapy of Unresectable Colorectal Cancer

Project description:Interventions: investigational material(s) Generic name etc : Irinotecan hydrochloride | Tegafur/Gimeracil/ Oteracil Potassium | Fluorouracil | Levofolinate Calcium INN of investigational material : Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : Irinotecan hydrochloride : injection, Fluorouracil : injection, Levofolinate Calcium : injection, Tegafur/Gimeracil/ Oteracil Potassium capsule : oral Primary outcome(s): Progression free survival Study Design: Open label, multicenter phase 2 / 3 study

| 97751 | ecrin-mdr-crc

Phase II Study of S-1 plus LV (1 week on and 1 week off) as First-line Treatment for Patients with metastatic colorectal cancer.

Project description:Intervention name : S-1 (tegafur + gimeracil + oteracil potassium) INN of the intervention : S-1: tegafur, gimeracil, oteracil potassium Dosage And administration of the intervention : S-1 40-60 mg x 2/day was administered orally for one week followed by one week rest. Intervention name : LV (Levofolinate calcium) INN of the intervention : folic acid Dosage And administration of the intervention : LV 25 mg x 2/day was administered orally for one week along with S-1 followed by one week rest. Primary outcome(s): Efficacy, Safety Study Design: Open-label, Multi-center Study

| 2610136 | ecrin-mdr-crc

nal-IRI+5-FU/LV versus 5-FU/LV in post-gemcitabine metastatic pancreatic cancer: Randomized phase 2 trial in Japanese patients.

Project description:BackgroundIn the NAPOLI-1 phase 3 trial, liposomal irinotecan (nal-IRI) +5-fluorouracil/leucovorin (5-FU/LV) significantly increased mPFS versus 5-FU/LV (3.1 vs. 1.5 months [unstratified HR = 0.56, p = 0.0001]) in patients with mPAC that progressed on prior gemcitabine-based therapy. This randomized phase 2 trial evaluated nal-IRI+5-FU/LV tolerability (Part 1), safety, and efficacy (Part 2; outcomes reported here) in Japanese patients with mPAC that progressed on gemcitabine-based therapy.MethodsPatients were randomized 1:1 and stratified by KPS (70 and 80 vs. ≥90) and baseline albumin (≥4.0 g/dl vs. <4.0 g/dl). Primary endpoint was PFS; secondary endpoints were ORR, DCR, OS, TTF, CA19-9 response, and QoL. The ITT population comprised all randomized patients.ResultsPatient characteristics differed between nal-IRI+5-FU/LV (n = 40) and 5-FU/LV (n = 39) arms, including baseline hepatic lesions (63% vs. 51%), stage IV disease at diagnosis (78% vs. 51%), and post-study anticancer therapy (55% vs. 72%). Investigator-assessed mPFS increase with nal-IRI+5-FU/LV was clinically meaningful and statistically significant versus 5-FU/LV (2.7 vs. 1.5 months, HR = 0.60). Independently assessed mPFS showed similar trends (1.7 vs. 1.6 months, HR = 0.79). mOS was 6.3 months with nal-IRI+5-FU/LV and not reached with 5-FU/LV. ORR increased significantly with nal-IRI+5-FU/LV versus 5-FU/LV (18% vs. 0, rate difference 17.5). Commonly reported grade ≥3 treatment-emergent AEs were decreased neutrophil count (37% vs. 3%), decreased white blood cell count (20% vs. 0), and diarrhea (17% vs. 3%).ConclusionsIn conclusion, clinically meaningful and statistically significant gains in investigator-assessed PFS and ORR were observed with nal-IRI+5-FU/LV versus 5-FU/LV in Japanese patients, with no new or unexpected safety signals. (Clinicaltrials.gov ID: NCT02697058).

| S-EPMC7774735 | biostudies-literature

Quality-adjusted survival with combination nal-IRI+5-FU/LV vs 5-FU/LV alone in metastatic pancreatic cancer patients previously treated with gemcitabine-based therapy: a Q-TWiST analysis.

Project description:BackgroundIn the NAPOLI-1 Phase 3 trial, nal-IRI+5-fluorouracil and leucovorin (5-FU/LV) significantly improved median overall survival (6.1 vs 4.2 months, P=0.012) and progression-free survival (3.1 vs 1.5 months, P=0.0001) vs 5-FU/LV alone in metastatic pancreatic adenocarcinoma patients previously treated with gemcitabine-based therapy. This analysis evaluated between treatment differences in quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST).MethodsOverall survival was partitioned into time with grade ⩾3 toxicity (TOX), disease progression (REL), and time without disease progression symptoms or grade ⩾3 toxicity (TWiST). Mean Q-TWiST was calculated by weighting time spent by a utility of 1.0 for TWiST and 0.5 for TOX and REL. In threshold analyses, utility for TOX and REL were varied from 0.0 to 1.0.ResultsPatients in nal-IRI+5-FU/LV (n=117) vs 5-FU/LV (n=119) had significantly more mean time in TWiST (3.4 vs 2.4 months) and TOX (1.0 vs 0.3 months) but similar REL (2.5 vs 2.7 months). In the base case, nal-IRI+5-FU/LV patients had 1.3 months (95% CI, 0.4-2.1; 5.1 vs 3.9) greater Q-TWiST (threshold analyses range: 0.9-1.6 months).ConclusionsWithin NAPOLI-1, nal-IRI+5-FU/LV resulted in statistically significant and clinically meaningful gains in quality-adjusted survival vs 5-FU/LV alone.

| S-EPMC5482729 | biostudies-literature

Human rpL3 plays a crucial role in cell response to nucleolar stress induced by 5-FU and L-OHP.

Project description:Recent evidence showed that a variety of DNA damaging agents including 5-FU and L-OHP impairs ribosomal biogenesis activating a ribosomal stress pathway. Here, we demonstrate that in lung and colon cancer cell lines devoid of p53, the efficacy of 5-FU and L-OHP chemotherapy depends on rpL3 status. Specifically, we demonstrate that ribosomal stress induced by 5-FU and L-OHP is associated to up-regulation of rpL3 and its accumulation as ribosome-free form. We show that rpL3 participates in the cell response to chemotherapy acting as a critical regulator of cell cycle, apoptosis and DNA repair, by modulating p21 expression. Moreover, we demonstrate that rpL3 is able to control DNA repair also independently from p21 status of cell. It is noteworthy that silencing of rpL3 abolishes the cytotoxic effects of 5-FU and L-OH indicating that the loss of rpL3 makes chemotherapy drugs ineffective. Taking together our results shed light on 5-FU and L-OHP mechanism of action and contribute to more effective clinical use of these drugs in cancer therapy.

| S-EPMC4294388 | biostudies-literature

Oxaliplatin/capecitabine vs oxaliplatin/infusional 5-FU in advanced colorectal cancer: the MRC COIN trial.

Project description:COIN compared first-line continuous chemotherapy with the same chemotherapy given intermittently or with cetuximab in advanced colorectal cancer (aCRC).Choice between oxaliplatin/capecitabine (OxCap) and oxaliplatin/leucovorin (LV)/infusional 5-FU (OxFU) was by physician and patient choice and switching regimen was allowed. We compared OxCap with OxFU and OxCap+cetuximab with OxFU+cetuximab retrospectively in patients and examined efficacy, toxicity profiles and the effect of mild renal impairment.In total, 64% of 2397 patients received OxCap(± cetuximab). Overall survival, progression free survival and overall response rate were similar between OxCap and OxFU but rate of radical surgeries was higher for OxFU. Progression free survival was longer for OxFU+cetuximab compared with OxCap+cetuximab but other efficacy measures were similar. Oxaliplatin/LV/infusional 5-FU (± cetuximab) was associated with more mucositis and infection whereas OxCap(± cetuximab) caused more gastrointestinal toxicities and palmar-plantar erythema. In total, 118 patients switched regimen, mainly due to toxicity; only 16% came off their second regimen due to intolerance. Patients with creatinine clearance (CrCl) 50-80 ml min(-1) on OxCap(± cetuximab) or OxFU+cetuximab had more dose modifications than those with better renal function.Overall, OxFU and OxCap are equally effective in treating aCRC. However, the toxicity profiles differ and switching from one regimen to the other for poor tolerance is a reasonable option. Patients with CrCl 50-80 ml min(-1) on both regimens require close toxicity monitoring.

| S-EPMC3461171 | biostudies-other

Phase II Study of S-1 plus LV (1 week on and 1 week off) as First-line Treatment for Patients with metastatic colorectal cancer.

Project description:Interventions: investigational material(s) Generic name etc : S-1 (tegafur + gimeracil + oteracil potassium) INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : S-1 40-60 mg x 2/day was administered orally for one week followed by one week rest. Generic name etc : LV (Levofolinate calcium) INN of investigational material : folic acid Therapeutic category code : 392 Antidotes Dosage and Administration for Investigational material : LV 25 mg x 2/day was administered orally for one week along with S-1 followed by one week rest. Primary outcome(s): Efficacy, Safety Study Design: Open-label, Multi-center Study

| 99793 | ecrin-mdr-crc

An exploratory study of treatment sensitivity and prognostic factors in a efficacy and safety study of mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naive unresectable advanced or recurrent colorectal cancer

Project description:Intervention name : mFOLFOX6 + panitumumab INN of the intervention : Fluorouracil, calcium levofolinate, oxaliplatin, panitumumab Dosage And administration of the intervention : Group P; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, panitumumab: 6 mg/kg; mFOLFOX6 + panitumumab combination therapy, once every two weeks Control intervention name : mFOLFOX6 + bevacizumab INN of the control intervention : Fluorouracil, calcium levofolinate, oxaliplatin, bevacizumab Dosage And administration of the control intervention : Group B; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, bevacizumab: 5 mg/kg; mFOLFOX6 + bevacizumab combination therapy, once every two weeks Primary outcome(s): exploratory Overall survival (OS) Timeframe: Up to approximately 63 months OS obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study evaluate the relationship between OS and gene mutations. OS will be measured as the time from the date of randomization to the date of death due to any causes. Study Design: Exploratory analysis

| 2658055 | ecrin-mdr-crc

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