Browse
Submit Data
Databases
API
Help

Dataset Information

0 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Randomised Phase II trial of irinotecan with hyaluronic acid (HyCAMP) versus irinotecan as treatment for patients with metastatic colorectal cancer who have failed 5-FU based chemotherapy

ABSTRACT: Interventions: This is an open-label, randomized Phase II study of HyCAMP versus irinotecan as second-line or subsequent-line treatment for metastatic colorectal cancer, for patients who have previously received 5-FU based chemotherapy. The mixture of HA and irinotecan will be given by intravenous infusion on day 1 of a 3-week cycle, up to a maximum of 8 cycles, with the control arm receiving irinotecan alone in the same treatment schedule. The treatment dose of HyCAMP has been shown to be safe in a recently completed Phase I study combining irinotecan with HA. Patients will be randomized in a 1:1 fashion to either 1) HyCAMP (irinotecan and HA) or 2) Control arm (irinotecan) Primary outcome(s): Incidence of Grade 3 and 4 diarrhoea[] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy

DISEASE(S): Metastatic Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2451960 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

Expression data from Irinotecan resistant LoVo cells comapred to parental LoVo cells

2014-07-18 | GSE59501 | GEO

Expression data from Irinotecan resistant LoVo cells comapred to parental LoVo cells

Project description:Irinotecan, an analogue of camptothecin, is frequently used in combination with various anticancer drugs or as a single agent in treatment of colorectal cancer. But drug resistance of tumor is still a major obstacle to overcome for the success of cancer treatment. In this study, We established chronic irinotecan resistant cell line for new marker to increase the sensitivity to irinotecan and investigated gene expression profiles of the irinotecan-resistant colorectal cancer cell line. To create stable CRC cell line chronically resistant to Irinotecan, LoVo cell was exposed to an initial Irinotecan concentration of 0.1 M-NM-<mol/L in RPMI 1640 supplemented with 10% FBS. When the growth of the cultured cells reaches at 80% confluency, cells were passaged twice at same drug concentration to ensure adaptation and then concentration of Irinotecan was sequentially increased in the same manner to 8 M-NM-<mol/L and then we investigated the gene expressions between parental colorectal cancer cell line, LoVo and Irinotecan resistant LoVo cell lines

2014-07-18 | E-GEOD-59501 | biostudies-arrayexpress

AOM/DSS tumors 5FU+Irinotecan treatment

Project description:AOM/DSS tumors 5FU+Irinotecan treatment

| PRJNA822417 | ENA

Irinotecan-induced gene expression changes in the rat intestine

2008-08-01 | GSE11722 | GEO

TAS-102, Irinotecan, and Bevacizumab in Pre-treated Metastatic Colorectal Cancer (TABAsCO), A Phase II Clinical Trial. ClinicalTrials.gov NCT04109924

Project description:Background: The efficacy of FOLFIRI plus an antiangiogenesis biologic agent as 2nd line therapy for metastatic colorectal adenocarcinoma is limited. TAS-102 is a novel oral antimetabolite with a distinct mechanism of action from fluoropyrimidines. We evaluated the antitumor efficacy of TAS-102, irinotecan and bevacizumab in patients with pre-treated, advanced colorectal adenocarcinoma in a multicenter, phase II, single-arm study. Methods: Patients with advanced colorectal adenocarcinoma who had progressed after oxaliplatin and fluoropyrimidine and were eligible for treatment with bevacizumab were treated with irinotecan, bevacizumab, and TAS-102 in 28-day cycles. The primary endpoint was progression-free survival (PFS). Results: We enrolled 35 evaluable patients. The study was positive. The median PFS was 7.9 (90% CI 6.2-11.8) months (vs. 6 months in historical control, p=0.018). The median overall survival was 16.5 (90% CI 9.8-17.5) months. Sixty-seven percent of patients experienced grade 3 or higher treatment-related adverse events. The most common toxicities were hematological (neutropenia) and gastrointestinal (diarrhea, nausea, and vomiting). Conclusions: Irinotecan, TAS-102 and bevacizumab is an active 2nd line therapy for patients with metastatic colorectal adenocarcinoma. Neutropenia is common and can affect dose density/intensity mandating use of G-CSF. A randomized study versus standard of care therapy is warranted.

2024-08-26 | GSE275628 | GEO

Transcription profiling of rat intestine to investigate Irinotecan-induced changes

Project description:The regional specificity and timing of gene activation following chemotherapy, and how this relates to subsequent mucositis development is currently unknown. The aim of the study was therefore to determine the early time course of gene expression changes along the gastrointestinal tract (GIT) of the DA rat following irinotecan treatment, so as to provide an insight into the genetic component of mucositis. We have found that changes in gene expression following irinotecan occur by 1 hour, and persist for at least 72 h after treatment. Overall changes in gene expression are similar along the GIT, however there is temporal variability between regions. Experiment Overall Design: Thirty female DA rats were placed in groups (n = 6) and treated with 200 mg/kg i.p. of irinotecan. Animals were killed at 0, 1, 6, 24 and 72 h and samples of stomach, jejunum and colon collected. These times were chosen to represent very early responses to treatment, up to the time of peak damage and morphological changes. The 0 h group did not receive irinotecan and acted as experimental controls. RNA was extracted from whole tissue samples. RNA was pooled into 2 per group (n = 3) to allow for replication of experiment. Each sample was then hybridised to Affymetrix GeneChip Arrays (Rat 230 2.0).

2008-10-21 | E-GEOD-11722 | biostudies-arrayexpress

Evaluation of Eribulin Combined with Irinotecan for Treatment of Pediatric Cancer Xenografts

Project description:Eribulin, irinotecan, and the combination were studied in ES4 xenograft model. RNAs from xenograft tumors were harvested at 24h and 144h after single agent or combination treatment to analyze gene expression.

2020-03-10 | GSE146687 | GEO

Effectiveness of irinotecan plus trabectedin in a desmoplastic small round cell tumor patient-derived xenograft

Project description:Desmoplastic small round cell tumor (DSRCT) is a rare and incurable malignancy characterized by the oncogenic EWSR1-WT1 transcription factor. This study exploited a novel DSRCT patient-derived xenograft (PDX), which reproduces histomorphological and molecular characteristics of the paired clinical tumor, to comparatively assess the activity of cytotoxic and targeted anticancer agents. Anti-tumor effect was moderate for single-agent doxorubicin, pazopanib and larotrectenib [maximum tumor volume inhibition (max TVI): 55-66%] while trabectedin had a higher effect (max TVI: 82%). Single-agent vinorelbine, irinotecan and eribulin achieved a nearly complete tumor growth inhibition (max TVI: 96-98%), although tumors started to re-growth after the end of treatment. Combination of irinotecan with either eribulin or trabectedin resulted in complete responses which were maintained until the end of the experiment for irinotecan plus trabectedin. Irinotecan-based combinations almost completely abrogated the expression of proteins involved in the G2/M checkpoint preventing cell entrance in mitosis and induced apoptotic and necroptotic cell death. This study emphasizes the importance of patient-derived pre-clinical models to explore new treatments in DSRCT and fosters clinical investigation in the activity of irinotecan plus trabectedin.

2023-05-29 | GSE220172 | GEO

Fasting and the side effects of irinotecan

Project description:We investigated the transcriptional responses of fasting against side effects of irinotecan chemotherapy in both tumor and healthy liver tissue

2019-05-03 | GSE72484 | GEO

Effectiveness of irinotecan plus trabectedin in a desmoplastic small round cell tumor patient-derived xenograft [II]

2023-05-29 | GSE227897 | GEO