Phase II study of fosfluridine tidoxil in an oral multiple dose schedule given once-a-day for 7 consecutive days every 2 weeks in patients with advanced breast and colorectal cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Patiens With Confirmed Metastatic Breast Or Colorectal Cancer. Breast:pats Should Have Received/failed At Least 1 But No More Than 2 Lines Of Chemotherapy With Taxanes And/or Anthracyclines For Me...,Patiens With Confirmed Metastatic Breast Or Colorectal Cancer. Breast:pats Should Have Received/failed At Least 1 But No More Than 2 Lines Of Chemotherapy With Taxanes And/or Anthracyclines For Metastatic Disease. Colorectal:pats Not Eligible For 1. Chemotherapy Of 5-fu With Either Oxaliplatin/irinotecan/bevacizumab. Pats Are Eligible If Having Received 1.line Chemotherapy Of 5-fu With Either Oxaliplatin/irinotecan/bevacizumab, But Unable To Tolerate >2 Cycl. Due To Treatment-related Toxicity
PROVIDER: 2517452 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:The aim of our study was to evaluate the ability of miRNA expression patterns to predict chemotherapy response in a cohort of 39 patients with metastatic colorectal carcinoma To define miRNA signature, samples were obtained from tumor tissue samples of 39 patients . Patients were divided into responders or non-responders according to tresponse treatment with a chemotherapy regimen that included fluoropyrimidines and either oxaliplatin or irinotecan .Tumor response was evaluated by conventional methods according to the standard RECIST 1.0 criteria: a complete response (CR) was defined as the disappearance of all measurable and evaluable evidence of disease; a partial response (PR) was defined as a > 30% decrease in the sum of the longest diameters of target lesions; stable disease (SD) was considered if the tumor burden decreased less than 30% or increased less than 20%; and progressive disease (PD) was indicated by a >20% increase in the sum of the longest diameters of target lesions or the appearance of any new lesion. Patients were classified according to best response to chemotherapy in two groups: those that achieved an objective response (Responders [R]: CR + PR) and those that did not (Non-responders [NR]: SD + PD). Mature human miRNA expression was detected and quantified using the TaqMan® Low Density Arrays (TLDA). The Human MicroRNA Card Set v2.0 array is a two card set containing a total of 384 TaqMan® MicroRNA Assays per card to enable accurate quantification of 667 human microRNAs, all catalogued in the miRBase database. Expression of target miRNAs was normalized in relation to the expression of MammU6. Cycle threshold (Ct) values were calculated using the SDS software v.2.3 using automatic baseline settings and a threshold of 0.2. Relative quantification of miRNA expression was calculated by the 2−ΔCt method (Applied Biosystems user bulletin no. 2 (P/N 4303859)).
2014-08-12 | E-GEOD-48664 | biostudies-arrayexpress
Project description:Primary objectives: To evaluate the objective tumour response in patients with advanced colorectal cancer when treated with CP-4055 for infusion D1-5/4w.
Primary endpoints: Tumour response defined as Complete Response (CR) and/or Partial Response (PR), characterized by measuring the target lesions, and according to the RECIST criteria.The Response Rate (= PR + CR) will be estimated and a 95 % confidence interval calculated.
| 2521306 | ecrin-mdr-crc
Project description:Primary objectives: prevention of growth of liver metastase during liver expansion
Primary endpoints: Total sum of liver metastases diameter for each patient measured by CT as baseline at start of cetuximab and evaluated by CT 6 weeks after portal embolisation. The follow-up CT will be evaluated for changes in the total sum of lesion diameters and expansion of the contralateral liver volume. occurence of new lesions will be registered.
| 2521756 | ecrin-mdr-crc
Project description:Intervention name : TAK-931
INN of the intervention : -
Dosage And administration of the intervention : TAK-931 50 mg, capsules, orally, once daily for 14 days, followed by 7-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 1 year).
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Primary outcome(s): safety
Percentage of Participants with Dose Limiting Toxicities (DLTs) in Western Safety Cohort
Timeframe; Cycle 1 (each cycle = 21 days)
DLT: Any following event related to TAK-931 assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03; Non-febrile Grade 4 neutropenia lasting more than 7 consecutive days; Febrile neutropenia: Grade >=3 neutropenia with fever and/or
infection; Grade 4 thrombocytopenia; Grade >=3 thrombocytopenia of any duration accompanied by Grade 2 bleeding or requiring transfusion; delay in the initiation of cycle 2 by more than 14 days due to a lack of adequate recovery of treatment-related hematological or nonhematologic toxicities; Grade 2 ejection fraction decreased by ECHO or MUGA scan; Grade 4 laboratory abnormalities; other Grade 2 nonhematologic toxicities considered by the investigator to be related to study drug and dose-limiting; Participants receiving <50% of doses (<7 doses) of the planned TAK-931 dosing in cycle 1 due to study drug-related adverse events (AEs); Grade >=3 nonhematologic toxicity with the few exceptions: Grade 3 arthralgia/ myalgia, fatigue, laboratory abnormalities, nausea and/or emesis or diarrhea.
safety
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Dose Modifications and TEAEs Leading to Treatment Discontinuation in Western Safety Cohort
Timeframe; From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
efficacy
Disease Control Rate (DCR) in Tumor Specific Cohorts
Timeframe; Up to end of treatment (Up to approximately 14 months)
DCR is defined as percentage of participants documented to have unconfirmed complete response (CR), partial response (PR) or stable disease (SD) >=6 weeks from treatment initiation according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) as the best response.. CR is defined as disappearance of all lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of lesions, taking as reference the baseline sum LD. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. (PD is defined as at least a 20% increase in the sum of the LD of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Study Design: Open-Label, Parallel Arm Study
| 2611645 | ecrin-mdr-crc
Project description:Interventions: investigational material(s)
Generic name etc : TAK-931
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : TAK-931 50 mg, capsules, orally, once daily for 14 days, followed by 7-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 1 year).
control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -
Primary outcome(s): safety
Percentage of Participants with Dose Limiting Toxicities (DLTs) in Western Safety Cohort
Timeframe; Cycle 1 (each cycle = 21 days)
DLT: Any following event related to TAK-931 assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03; Non-febrile Grade 4 neutropenia lasting more than 7 consecutive days; Febrile neutropenia: Grade >=3 neutropenia with fever and/or
infection; Grade 4 thrombocytopenia; Grade >=3 thrombocytopenia of any duration accompanied by Grade 2 bleeding or requiring transfusion; delay in the initiation of cycle 2 by more than 14 days due to a lack of adequate recovery of treatment-related hematological or nonhematologic toxicities; Grade 2 ejection fraction decreased by ECHO or MUGA scan; Grade 4 laboratory abnormalities; other Grade 2 nonhematologic toxicities considered by the investigator to be related to study drug and dose-limiting; Participants receiving <50% of doses (<7 doses) of the planned TAK-931 dosing in cycle 1 due to study drug-related adverse events (AEs); Grade >=3 nonhematologic toxicity with the few exceptions: Grade 3 arthralgia/ myalgia, fatigue, laboratory abnormalities, nausea and/or emesis or diarrhea.
safety
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Dose Modifications and TEAEs Leading to Treatment Discontinuation in Western Safety Cohort
Timeframe; From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
efficacy
Disease Control Rate (DCR) in Tumor Specific Cohorts
Timeframe; Up to end of treatment (Up to approximately 14 months)
DCR is defined as percentage of participants documented to have unconfirmed complete response (CR), partial response (PR) or stable disease (SD) >=6 weeks from treatment initiation according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) as the best response.. CR is defined as disappearance of all lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of lesions, taking as reference the baseline sum LD. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. (PD is defined as at least a 20% increase in the sum of the LD of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Study Design: Open-Label, Parallel Arm Study
| 102033 | ecrin-mdr-crc
Project description:Chimeric antigen receptors (CARs) are synthetic receptors for antigen that reprogram T cell specificity, function and persistence. Patient-derived CAR T cells have demonstrated remarkable efficacy against a range of B-cell malignancies, and early trial results suggest activity in multiple myeloma. Despite high complete response rates, relapses occur in a large fraction of patients, some of which are antigen-negative and others antigen-low. Unlike mechanisms resulting in complete and permanent antigen loss, those leading to antigen-low tumour escape remain obscure. In murine leukaemia models, we show that CARs provoke reversible antigen loss through trogocytosis, an active process whereby target antigen is transferred to T cells, thereby decreasing target density on tumour cells and abating T cell activity by promoting fratricide killing and exhaustion. These mechanisms affect both CD28 and 4-1BB-based CARs, albeit differentially, depending on antigen density. They can be offset by cooperative killing and combinatorial targeting.
2019-03-27 | GSE126753 | GEO
Project description:Ribba2012 - Low-grade gliomas, tumour growth inhibition model
Using longitudinal mean tumour diameter (MTD) data, this model describe the size evolution of low-grade glioma (LGG) in patients treated with chemotherapy or radiotherapy.
This model is described in the article:
A tumour growth inhibition model for low-grade glioma treated with chemotherapy or radiotherapy
Ribba B, Kaloshi G, Peyre M, Ricard D, Calvez V, Tod M, Cajavec-Bernard B, Idbaih A, Psimaras D, Dainese L, Pallud J, Cartalat-Carel S, Delattre JY, Honnorat J, Grenier E, Ducray F.
Clin. Cancer Res. 2012 Sep; 18(18): 5071-5080
Abstract:
PURPOSE: To develop a tumor growth inhibition model for adult diffuse low-grade gliomas (LGG) able to describe tumor size evolution in patients treated with chemotherapy or radiotherapy.
EXPERIMENTAL DESIGN: Using longitudinal mean tumor diameter (MTD) data from 21 patients treated with first-line procarbazine, 1-(2-chloroethyl)-3-cyclohexyl-l-nitrosourea, and vincristine (PCV) chemotherapy, we formulated a model consisting of a system of differential equations, incorporating tumor-specific and treatment-related parameters that reflect the response of proliferative and quiescent tumor tissue to treatment. The model was then applied to the analysis of longitudinal tumor size data in 24 patients treated with first-line temozolomide (TMZ) chemotherapy and in 25 patients treated with first-line radiotherapy.
RESULTS: The model successfully described the MTD dynamics of LGG before, during, and after PCV chemotherapy. Using the same model structure, we were also able to successfully describe the MTD dynamics in LGG patients treated with TMZ chemotherapy or radiotherapy. Tumor-specific parameters were found to be consistent across the three treatment modalities. The model is robust to sensitivity analysis, and preliminary results suggest that it can predict treatment response on the basis of pretreatment tumor size data.
CONCLUSIONS: Using MTD data, we propose a tumor growth inhibition model able to describe LGG tumor size evolution in patients treated with chemotherapy or radiotherapy. In the future, this model might be used to predict treatment efficacy in LGG patients and could constitute a rational tool to conceive more effective chemotherapy schedules.
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2014-03-01 | BIOMD0000000521 | BioModels
Project description:Interventions: colorectal lesions more than 10 cm in diameter
colorectal lesions from 5cm to 10 cm in diameter
Primary outcome(s): En bloc resection rate
Study Design: Parallel Non-randomized
| 2660360 | ecrin-mdr-crc
Project description:An evaluation of biopsies from patients with in-transit extremity melanoma who have been treated with ADH-1 followed by melphalan in the setting of isolated limb infusion Gene expression profiles were obtained from 28 lesions across 15 patients and evaluated for expression values that correlated with ADH-1 treatment given 4-8hrs prior to melphalan isolated limb infusion Chemotherapy response analysis: complete response - CR; partial response - PR; stable disease - SD; progressive disease - PD; lost to follow-up - LTU/F ADH-1 treatment classification: 'pre' - lesions obtained prior to any treatment with ADH-1; 'post' - lesions obtained just prior to ILI with melphalan after 1 treatment with ADH-1; '2nd' - lesions obtained after a 2nd dose of ADH-1 given 8 days after melphalan ILI
2011-01-01 | E-GEOD-22968 | biostudies-arrayexpress