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204 results for

Clinical Index of Stable Febrile Neutropenia

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181. Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer

plus capeciteabine that did not cause a selected Grade 3 toxicity in >= 2 participants, which is any of 1) Grade 3 or 4 non-hematologic toxicity (Grade 3 asthenia was not considered a DLT unless lasting >3 days, 2) Grade 3 diarrhea lasting >2 days on optimal medical therapy or associated with fever or dehydration. 3) Grade 4 neutropenia lasting ≥ 3 days or Grade 4 febrile neutropenia, 4) Grade 4 thrombocytopenia lasting ≥3 days or associated with bleeding or requiring platelet transfusion, 5 (...) participants, which is any of 1) Grade 3 or 4 non-hematologic toxicity (Grade 3 asthenia was not considered a DLT unless lasting >3 days, 2) Grade 3 diarrhea lasting >2 days on optimal medical therapy or associated with fever or dehydration. 3) Grade 4 neutropenia lasting ≥ 3 days or Grade 4 febrile neutropenia, 4) Grade 4 thrombocytopenia lasting ≥3 days or associated with bleeding or requiring platelet transfusion, 5) Delayed recovery [to ≥ National Cancer Institute Common Terminology Criteria

2008 Clinical Trials

182. Study of Sorafenib and Infusional 5-Fluorouracil in Advanced Hepatocellular Carcinoma (HCC)

entry. G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity, such as febrile neutropenia, when clinically indicated, or at the discretion of the investigator; however, they may not be substituted for a required dose reduction. Chronic Erythropoietin treatment prior to the study entry or during the study is permitted. Use of ritonavir and grapefruit juice. Prior use of Raf-Kinase inhibitors, MEK or Farnesyl Transferase Inhibitors. Any investigational drug (...) administered as a single agent. Investigators reported seven patients with partial responses, five minor responses and 59 with stable disease for at least 4 months. Median overall survival was 9.2 months and median time to progression 4.2 months. This study showed that Sorafenib was well tolerated and side-effects were manageable and reversible. Rationale 5-Fluorouracil (5-FU) is a widely used agent for patients with unresectable advanced HCC, with objective responses rates around 10%. Compared to bolus

2008 Clinical Trials

183. Phase 1b Multicenter Study of Carfilzomib With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma

, or dexamethasone: Nonhematologic ≥ Grade 2 neuropathy with pain ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, diarrhea, hyperglycemia due to dexamethasone, and rash due to lenalidomide) ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal supportive therapy ≥ Grade 4 fatigue persisting > 7 days Treatment delay for toxicity > 21 days Hematologic Grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm³) > 7 days Febrile neutropenia (ANC < 1,000/mm³ with fever ≥ 38.3ºC) Grade 4 (...) for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 84 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Phase 1b Multicenter Dose Escalation Study of Carfilzomib With Lenalidomide and Dexamethasone for Safety and Activity in Relapsed Multiple Myeloma Study Start Date : May 2008 Actual Primary Completion Date : May 2013 Actual Study Completion Date : January 2016 Resource links provided

2008 Clinical Trials

184. Sequential Study to Treat Renal Cell Carcinoma

months of study Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator; however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study (...) mmHg systolic and/or >= 90 mmHG diastolic on medication). History of HIV infection or chronic hepatitis B or C Active clinically serious infections (> grade 2 NCI-CTC version 3.0) Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry) Patients with seizure disorder requiring medication (such as steroids or anti

2008 Clinical Trials

185. Neutropaenic Patients and Neutropaenic Regimes

neutropenia patients although its use in the UK is still low. [ ] These are patients who are haemodynamically stable, who do not have acute leukaemia or evidence of organ failure, and who do not have pneumonia, an indwelling venous catheter or severe soft tissue infection. Quinolone with amoxicillin plus clavulanic acid is the preferred choice given the rise in Gram-positive febrile neutropenia episodes. [ ] Oral quinolone therapy should not be used in patients who have taken a quinolone antibacterial (...) of incidental neutropenia in adulthood. Ann Hematol. 2006 Oct85(10):705-9. Epub 2006 Jun 29. ; Treatment of febrile neutropenia and prophylaxis in hematologic malignancies: a critical review and update. Adv Hematol. 20142014:986938. doi: 10.1155/2014/986938. Epub 2014 Nov 27. ; European Society for Medical Oncology (2010) ; The Multinational Association for Supportive Care in Cancer (MASCC) risk index score: 10 years of use for identifying low-risk febrile neutropenic cancer patients. Support Care Cancer

2008 Mentor

186. Invasive aspergillosis: is treatment with 'inexpensive' amphotericin B cost-saving if 'expensive' voriconazole is only used on demand

an investigation of the costs from multiple hospital locations and further assessment of specific patient groups (e.g. patients with febrile neutropenia or other immunosuppressed conditions, or patients of different ages). Source of funding None stated. Bibliographic details Garbino J, Schnetzler G, Roberts C. Invasive aspergillosis: is treatment with 'inexpensive' amphotericin B cost-saving if 'expensive' voriconazole is only used on demand. Swiss Medical Weekly 2006; 136(39-40): 624-630 PubMedID DOI Other (...) patients. J Antimicrob Chemother 2005;55:352-61. Bates DW, Su L, Yu DT, et al. Mortality and costs of acute renal failure associated with amphotericin B therapy. Clin Infect Ther 2001;132:301-2. Kaiser L, Huguenin T, Lew PD, et al. Invasive aspergillosis. Clinical features of 35 proven cases at a single institution. Medicine 1998;77:188-94. Indexing Status Subject indexing assigned by NLM MeSH Acute Kidney Injury /economics /etiology; Amphotericin B /adverse effects /economics /therapeutic use

2006 NHS Economic Evaluation Database.

187. A new decision model for cost-utility comparisons of chemotherapy in recurrent metastatic breast cancer

benefits and costs. Outcomes assessed in the review The review assessed the following positive outcomes and side-effects associated with each treatment regimen: Overall response rate, stable disease, early progressive disease, infections, hospitalised for infection, febrile neutropenia (FN), hospitalised for FN (3 days), severe neurotoxicity, severe fluid retention, severe arthralgia/myalgia or skin reactions, and death associated with infection and FN. Study designs and other criteria for inclusion (...) with anthracycline-resistant metastatic breast cancer, and the selection of dosage rates appropriate to this category of patient. Results of the review The following outcome results, for docetaxel and paclitaxel respectively,were selected for inclusion in the model: Overall response rate = 47% and 21%, stable disease = 33% and 59%, early progressive disease = 20% for both therapies, infections = 25% and 23%,hospitalised for infection = 25% of infections, febrile neutropenia (FN) = 22% and 12.5%, hospitalised

1996 NHS Economic Evaluation Database.

188. Cost-utility analysis of taxane therapy

duration of response was estimated to be six months, the disease being stable for three months and the one year mortality rate was assumed to be 57%. The response duration rates and mortality rates were assumed to be the same for both drugs. It was assumed that 25% of infections and incidents of febrile neutropenia would require hospitalisation. Measure of benefits used in the economic analysis The measure of benefits was Quality Adjusted Life Years (QALYs) gained. A Markov model was used to estimate (...) of effectiveness and key assumptions The frequency of adverse events associated with the use of paclitaxel or docetaxel respectively were as follows: infection, 23% and 26%; febrile neutropenia, 12.5% and 22%; death associated with infection and febrile neutropenia, 1.0% and 0.8%; severe neurotoxicity, 7% and 3.5%; severe fluid retention, 0% and 7%; and severe arthralgia, myalgia or skin reaction, 16% and 12%. The response rates for paclitaxel and docetaxel were found to be 21% and 47% respectively. The median

1997 NHS Economic Evaluation Database.

189. Cost-effectiveness analysis comparing liposomal anthracyclines in the treatment of AIDS-related Kaposi's sarcoma

trials, with variance in clinical and resource estimates of response rates (+/-10%), rates of growth factor use (+/-6%), costs of treatment of febrile neutropenia (an additional $300/responder) and dosage regimen. A comparison was also made using both higher dose and higher efficacy for liposomal daunorubicin and using an assumption of six cycles of treatment for both strategies. Estimated benefits used in the economic analysis Among severely immunocompromised patients with KS who received pegylated (...) of liposomal doxorubicin versus bleomycin and vincristine in the treatment of AIDS-related Kaposi's sarcoma. Journal of Clinical Oncology 1998;16:683-691. Gill P S, Wernz J, Scadden D T, et al. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. Journal of Clinical Oncology 1996;14:2353-2364. Indexing Status Subject indexing assigned by NLM MeSH Acquired Immunodeficiency Syndrome /complications; Antibiotics, Antineoplastic

1998 NHS Economic Evaluation Database.

190. A pilot study to evaluate the feasibility of using willingness to pay as a measure of value in cancer supportive care: an assessment of amifostine cytoprotection

chemotherapy or to a control group. Study design Randomised controlled trial. Analysis of effectiveness The analysis of the clinical study was based on intention to treat. The primary health outcomes used in the clinical study were the incidence (%) and absolute risk reduction (ARR)(%) in febrile neutropenia, renal toxicity and neurotoxicity, and the number of days in hospital. Effectiveness results An absolute risk reduction in febrile neutropenia of 11% (p=0.02) was observed (incidence rate: 21% without (...) amifostine, 10% with amifostine). Renal toxicity was 36% without amifostine compared to 10% with amifostine (p=0.003). This implied an absolute risk reduction of 26%. Neurotoxicity fell from 42% without amifostine to 31% with amifostine (p=0.029, absolute risk reduction of 11%). The total number of days in hospital with febrile neutropenia was 226 for controls and 89 for the amifostine patients (p=0.02). Clinical conclusions Pretreatment with amifostine reduces the cumulative hematologic, renal

1997 NHS Economic Evaluation Database.

191. Economic value of gemcitabine compared to cisplatin and etoposide in non-small cell lung cancer

, whereas theZubrod 0 (Karnofsky 100) values were 4% and 11%, respectively. Effectiveness results The median survival was 8.9 months (95% CI: 0 - 20) for the gemcitabine strategy, whereas the corresponding figure for cisplatin and etoposide was 7.3 months (95% CI: 0.4 - 44.8). The 'improved', 'stable' and 'worse' status were, at a midcycle, 9%, 82%, and 9%, respectively for the gemcitabine. The corresponding values for cisplatin and etoposide were 0%, 48%, and 52%, respectively. Clinical conclusions (...) and benefits were not combined since the intervention was regarded as the weakly dominant strategy. The most sensitive variables were febrile neutropenia treatment and the number of days of hospitalization required for administration of chemotherapy, on the part of the comparator. By varying the treatment costs of neutropenia, within the extremes of no occurrence of febrile neutropenia (reported as the most likely scenario) and severe febrile neutropenia, resulted in an increase of 171% in cost savings per

1996 NHS Economic Evaluation Database.

192. Cost effectiveness of treatment options in advanced breast cancer in the UK

and/or intravenous antibacterials, febrile neutropenia with hospitalisation, neutropenia without hospitalisation, death associated with infection or febrile neutropenia, severe neurotoxicity, severe oedema, severe skin condition, and severe nail condition. Study designs and other criteria for inclusion in the review The effectiveness data were derived from a systematic review of randomised controlled trials. Sources searched to identify primary studies Not stated. Criteria used to ensure the validity of primary (...) % with docetaxel, 21% with paclitaxel, and 38.4% with vinorelbine for progressive disease; 8.8% with docetaxel, 4% with paclitaxel, and 10% with vinorelbine for infection with hospitalisation and/or intravenous antibacterials; 7.3% with docetaxel, 7% with paclitaxel, and 0 with vinorelbine for febrile neutropenia with hospitalisation; 10.7% with docetaxel, 10% with paclitaxel, and 0 with vinorelbine for neutropenia without hospitalisation; 1.2% with docetaxel, and 0 with paclitaxel and vinorelbine for death

2001 NHS Economic Evaluation Database.

193. Posaconazole (NoxafilR)

versus host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy." The treatment regimen is 200 mg PO TID for the duration of time that the patient is at risk. In clinical trials, the average duration was 80 days in patients with HSCT and GVHD, and the average duration was 29 days in patients with henlatologic malignancies and prolonged neutropenia from chen~otherapy. Absorption is enhanced by food, particularly fatty meals; therefore the CLINICAL (...) Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely in~munocon~promised, such as hematopoietic stem cell transplant (HSCT) recipients with graft versus host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chenlotherapy." The treatment regimen is 200 mg PO TID for the duration of time that the patient is at risk. In clinical trials, the average duration of posaconazole treatment was 80

2006 FDA - Drug Approval Package

194. Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors

as tolerated and disease under study does not worsen. Outcome Measures Go to Primary Outcome Measures : Number of Participants With Dose-limiting Toxicities (DLT) in Part 1 [ Time Frame: Part 1 Baseline up to Day 28 ] DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of greater than or equal to (>=) 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet (...) participants experienced DLT after 21 days of treatment (Cycle 1). DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of >= 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to =< grade 1) which occurred in first 21 days of study and considered at least possibly

2005 Clinical Trials

195. Phase 1 Study Of Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors

Criteria Adverse Events (CTCAE), Version 3 [ Time Frame: Day 1 up to Day 21 of first cycle ] DLT defined as any of the following during the first cycle of treatment and attributable to PF-03814735: Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for >7 days or febrile neutropenia (ANC <1000/mm^3, fever ≥38 degrees Celsius; neutropenic infection (ANC <1000/mm^3); Gr 4 thrombocytopenia (platelets <25,000 cells/mm^3); ≥Gr 3 nausea, vomiting, or diarrhea, despite optimal (...) of aurora gene somatic mutations/amplification and pathway genes in relation to clinical response. Responses include CR: disappearance of all target lesions; PR: ≥30% decrease in sum of longest dimensions (LD) of target lesions referencing baseline sum LD; Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions; Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx

2007 Clinical Trials

196. Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer

was defined as grade 4 neutropenia causing treatment interruption for >14 days, febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with a bleeding episode requiring platelet transfusion, nausea and/or vomiting despite medical intervention/prophylaxis causing treatment interruption for >14 days, grade 3-4 asthenia/fatigue, any other grade >=3 nonhematologic toxicity except alopecia or transient arthralgia/myalgia (unless unresponsive to intervention), or interruption of study drug (...) Response by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Pretreatment visit then every 6 weeks thereafter (up to 51.6 months) ] RECIST for target lesions: Complete Response (CR)=disappearance of clinical and radiologic evidence of target lesions. Partial Response (PR)=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD. Stable disease (SD)=neither sufficient increase to qualify for Progressive Disease (PD) nor

2007 Clinical Trials

197. A Phase I/II Study to Determine the Maximum Tolerated Dose (MTD) and Safety of CC-4047 (Pomalidomide) Administered in Conjunction With Cisplatin and Etoposide

-hematological toxicity (excluding alopecia) occurring before Day 14 of pomalidomide dosing; febrile neutropenia (absolute neutrophil count [ANC] <1,000/µL and fever >101ºF, core temperature); grade 4 neutropenia of ≥7 days duration with onset on or before Day 14 of pomalidomide dosing; platelet count <25,000/µL occurring before Day 14 of pomalidomide dosing. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0, grades: 1=mild, 2=moderate, 3=severe, 4=life (...) of CC-4047 (pomalidomide) given in combination with cisplatin and etoposide in patients with extensive disease small cell lung cancer. Condition or disease Intervention/treatment Phase Carcinoma, Small Cell Drug: Pomalidomide Drug: Cisplatin Drug: Etoposide Phase 1 Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 22 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose

2007 Clinical Trials

198. Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer

Toxicities (DLTs) [ Time Frame: baseline through end of Phase 1 (up to 18 months) ] The following toxicities were considered DLT: CTCAE Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 × 10^9/L lasting ≥7 days. Febrile neutropenia (ANC <1.0 × 10^9/L, fever 38.5°C, and no documented infection). CTCAE Grade 4 thrombocytopenia (platelets <25.0 × 10^9/L). Any hemorrhage with CTCAE Grade ≥3 thrombocytopenia (50.0 × 10^9/L). CTCAE Grade ≥3 nonhematologic toxicity (excluding nausea, vomiting, or CTCAE (...) : Pemetrexed - Phase 1 Drug: Carboplatin - Phase 1 Drug: Pemetrexed - Phase 2 Drug: Carboplatin - Phase 2 Phase 1 Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 86 participants Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase 1 and 2 Clinical Trial of ALIMTA® (Pemetrexed) in Combination With Carboplatin in Patients With Recurrent

2007 Clinical Trials

199. Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer

], version 3.0: neutropenia (lasting >5 days), febrile neutropenia, documented infections related to neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, and neurosensory events; or death due to any cause. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored for this analysis at the date of last contact. Survival Without Grade 4 Toxicity [ Time Frame: Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (...) to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 260 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Randomized Phase 3 Study Comparing Pemetrexed-Carboplatin With Docetaxel-Carboplatin as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Study Start Date : October 2007 Actual Primary Completion Date

2007 Clinical Trials

200. The clinical effectiveness and cost-effectiveness of vinorelbine for breast cancer: a systematic review and economic evaluation

might result in more febrile neutropenia (15% versus 2%, P=0.001). Evidence from uncontrolled phase II studies appeared to complement the RCT findings but did not compensate for the lack of RCTs. These studies were compromised by potential biases, clinical diversity, statistical heterogeneity and a lack of precision. Cost information Four economic evaluations were included in the review. When comparing the cost-effectiveness of vinorelbine, paclitaxel and docetaxel, one study found vinorelbine (...) examined in the included trials. Funding NHS R&D Health Technology Assessment (HTA) programme, project number 00/15/03. Bibliographic details Lewis R, Bagnall A M, King S, Woolacott N, Forbes C, Shirran L, Duffy S, Kleijnen J, ter Riet G, Riemsma R. The clinical effectiveness and cost-effectiveness of vinorelbine for breast cancer: a systematic review and economic evaluation. Health Technology Assessment 2002; 6(14): 1-269 Original Paper URL Indexing Status Subject indexing assigned by NLM MeSH

2002 DARE.

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