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  • 1
    Electronic Resource
    Electronic Resource
    AMNIOTIC FLUID SQUALENE AND FETAL MATURITY (1979)
    Oxford, UK : Blackwell Publishing Ltd
    BJOG 86 (1979), S. 0 
    Details
    ISSN: 1471-0528
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Gas chromatographic profiles of neutral lipids in amniotic fluid pellets were analysed for 51 specimens collected from patients in the last two months of pregnancy. The most noticeable change was a large increase in squalene relative to other components in samples at term. By expressing data as a ratio of squalene to cholesterol (S/C), it was possible to accurately predict which amniotic fluid specimens came from patients whose pregnancies were of a gestation of 40 weeks or later. Highest values for S/C and for squalene were obtained for pregnancies which were several weeks overdue.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1111/j.1471-0528.1979.tb10711.x
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  • 2
    Electronic Resource
    Electronic Resource
    Pharmacokinetics and pharmacodynamics of prolonged oral etoposide in women with metastatic breast cancer (1995)
    Springer
    Cancer chemotherapy and pharmacology 37 (1995), S. 161-167 
    Details
    ISSN: 1432-0843
    Keywords: Key words Etoposide ; Pharmacology ; Breast cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract  The pharmacokinetics and pharmacodynamics of prolonged oral etoposide chemotherapy were investigated in 15 women with metastatic breast cancer who received oral etoposide 100 mg as a single daily dose for up to 15 days. There was considerable interpatient variability in the day 1 pharmacokinetic parameters: area under the plasma concentration time curve (AUC) (0–24 h) 1.95±0.87 mg/ml per min (mean±SD), apparent oral clearance 60.9±21.7 ml/min per 1.73 m2, peak plasma concentration 5.6± 2.5 μg/ml, time to peak concentration 73±35 min and half-life 220±83 min. However, intrapatient variability in systemic exposure to etoposide was much less with repeated doses. The intrapatient coefficient of variation (CV) of AUC for day 8 relative to day 1 was 20% and for day 15 relative to day 1 was 15%, compared to the day 1 interpatient CV of 45%. Neutropenia was the principal toxicity. Day 1 pharmacokinetic parameters were related to the percentage decrease in absolute neutrophil count using the sigmoidal Emax equation. A good fit was found between day 1 AUC and neutrophil toxicity (R 2=0.77). All patients who had a day 1 AUC 〉2.0 mg/ml per min had WHO grade III or IV neutropenia. The predictive performance of the models for neutrophil toxicity was better for AUC (percentage mean predictive error 5%, percentage root mean square error 18.1%) than apparent oral clearance, peak plasma concentration, or daily dose (mg/m2). A limited sampling strategy was developed to predict AUC using a linear regression model incorporating a patient effect. Data sets were divided into training and test sets. The AUC could be estimated using a model utilizing plasma etoposide concentration at only two time points, 4 h and 6 h after oral dosing (R 2=98.9%). The equation AUCpr=−0.376+ 0.631×C4h+0.336×C6h was validated on the test set with a relative mean predictive error of −0.88% and relative root mean square error of 6.4%. These results suggest monitoring of AUC to predict subsequent myelosuppression as a strategy for future trials with oral etoposide.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002800050382
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  • 3
    Electronic Resource
    Electronic Resource
    Phase I study of paclitaxel and oral etoposide in previously untreated non-small-cell and extensive small-cell lung cancer (1997)
    Springer
    Annals of oncology 8 (1997), S. 485-489 
    Details
    ISSN: 1569-8041
    Keywords: etoposide ; lung cancer ; paclitaxel ; phase I study
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose: This phase I study of paclitaxel and oral etoposide was performedto determine the safety of the combination in patients with advanced lungcancer who had received no prior chemotherapy, and to identify a dose forphase II testing. Patients and methods: Patients with locally advanced or metastaticnon-small-cell lung cancer (NSCLC) or extensive small-cell lung cancer (SCLC),who had received no prior chemotherapy were treated with intravenouspaclitaxel given as a three hour infusion (starting dose 100mg/m2) and oral etoposide, 100 mg daily for five days. Twoschedules of administration were used with the paclitaxel given on day 1(schedule A) or day 5 (schedule B) of a 21 day cycle. Results: Forty-nine patients were entered on the study, four of whom hadSCLC. All patients were evaluable for toxicity. The maximum tolerated dose waspaclitaxel 200 mg/m2 on day 1, in combination with oraletoposide 100 mg daily on days 1 to 5 (schedule A). The dose limitingtoxicities were mucositis, myalgia, diarrhoea, and paraesthesiae. Usingschedule B, myelosuppression, with febrile neutropenia was dose limiting ata paclitaxel dose of 160 mg/m2. Amongst the 45 patients withNSCLC there were three complete and eight partial responses (24%;95% CI 13%–40%), while there was one completeresponse in the four patients with SCLC. Conclusion: Paclitaxel 200 mg/m2 on day 1, with oraletoposide 100 mg daily on days 1 to 5 can be administered safely, and is therecommended dose for phase II studies.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008291606695
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  • 4
    Electronic Resource
    Electronic Resource
    A phase II study of gemcitabine in platinum pre-treated patients with advanced epithelial ovarian cancer (1998)
    Springer
    Annals of oncology 9 (1998), S. 1343-1345 
    Details
    ISSN: 1569-8041
    Keywords: gemcitabine ; ovarian cancer ; phase II ; single agent
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: Most patients with advanced ovarian cancer will relapse following platinum-based combination chemotherapy and be considered for second-line treatment. Gemcitabine, a nucleoside analogue, is active against a range of solid tumors. This phase II study investigated the activity of single-agent gemcitabine in patients with recurrent ovarian cancer. Patients and methods: Thirty-eight patients with FIGO stage III (34%) or IV (64%) ovarian cancer who were previously treated with platinum-containing regimens were enrolled. Patients received 1200 mg/m2 gemcitabine on days 1, 8 and 15 of a 28-day cycle. Results: Patients completed an average of 3.6 cycles. Two complete and three partial responses were seen in 36 evaluable patients, for an overall response rate of 13.9% (95% CI: 4.7%–29.5%). The median survival time was 6.7 months. Toxicities were generally mild. The most common were grade 3–4 neutropenia and grade 3 leukopenia reported in 23.7% and 10.5% of patients, respectively. One patient had grade 4 pulmonary toxicity. Conclusion: Single-agent gemcitabine is active and well tolerated in patients with recurrent ovarian cancer.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008469212268
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  • 5
    Electronic Resource
    Electronic Resource
    Repetitive high-dose therapy with ifosfamide, thiotepa and paclitaxel with peripheral blood progenitor cell and filgrastim support for metastatic and locally advanced breast cancer: Results of a phase I study (1999)
    Springer
    Annals of oncology 10 (1999), S. 479-481 
    Details
    ISSN: 1569-8041
    Keywords: high-dose therapy ; ifosfamide ; paclitaxel ; thiotepa ; transplantation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: This phase I study was designed to determine the optimal dosages of a novel repetitive high-dose therapy regimen for patients with metastatic breast cancer (MBC). Patients and methods: The planned treatment was three cycles of high-dose ifosfamide, thiotepa and conventional-dose paclitaxel delivered every 28 days with progressive dose-escalation in successive cohorts. Each cycle was supported by peripheral blood progenitor cells (PBPC) and filgrastim. Results: Twenty-three patients were entered into this trial. Of the planned 69 treatment cycles, 59 were delivered and fifteen patients completed all three cycles. The dose-limiting toxicities were renal tubular acidosis, encephalopathy, mucositis and enterocolitis. There was one treatment-related hemorrhagic death. Conclusions: The recommended doses for phase II or III studies are ifosfamide (10 g/m2), thiotepa (350 mg/m2) and paclitaxel (175 mg/m2).
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008317205955
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  • 6
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    Marizomib in Advanced Malignancies Including Multiple Myeloma (2016)
    The American Association for Cancer Research (AACR)
    Details
    Publication Date: 2016-09-16
    Description: Purpose: Marizomib (NPI-0052) is an irreversible proteasome inhibitor, derived from a marine actinomycete, with activity and specificity that is distinct from other proteasome inhibitors. Experimental Design: Phase I study (NPI-0052-102) evaluated the MTD, pharmacokinetics, and pharmacodynamics of marizomib intravenously on two dosing schedules. Results: Forty-two patients with advanced malignancies received Schedule A (0.1–0.9 mg/m 2 over 1–10 minutes on days 1, 8, 15 in 4-week cycles); 44 patients with relapsed and/or refractory multiple myeloma (RRMM) and other hematologic malignancies received Schedule B (0.075–0.6 mg/m 2 over 1 minute to 2 hours on days 1, 4, 8, 11, in 3-week cycles). The Schedule A recommended phase II dose was 0.7 mg/m 2 over 10 minutes; Schedule B was 0.5 mg/m 2 over 2 hours. The most common (〉25% of patients) related adverse events were fatigue, nausea, diarrhea, and infusion site pain (Schedule A); and fatigue (Schedule B). Overall response rate of 11% was seen in 27 efficacy-evaluable RRMM Schedule B patients (1 very good partial response, 3 partial responses, 4 minimal responses, and 12 stable disease). One Schedule A patient with transformed marginal zone lymphoma had complete response. Marizomib has a short half-life (〈30 minutes), with high volume of distribution (~15–416 L) and clearance (~0.9–22 L/minutes). Conclusions: Marizomib does not exhibit the severe peripheral neuropathy or hematologic toxicity observed with other proteasome inhibitors. Marizomib was generally well tolerated with low-dose dexamethasone, demonstrated activity in heavily pretreated RRMM patients, and warrants further evaluation. Clin Cancer Res; 22(18); 4559–66. ©2016 AACR .
    Print ISSN: 1078-0432
    Electronic ISSN: 1557-3265
    Topics: Medicine
    Published by The American Association for Cancer Research (AACR)
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  • 7
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    A phase 1b clinical trial of the CD40-activating antibody CP-870,893 in combination with cisplatin and pemetrexed in malignant pleural mesothelioma (2015)
    Oxford University Press
    Details
    Publication Date: 2015-11-26
    Description: Background Data from murine models suggest that CD40 activation may synergize with cytotoxic chemotherapy. We aimed to determine the maximum tolerated dose (MTD) and toxicity profile and to explore immunological biomarkers of the CD40-activating antibody CP-870,893 with cisplatin and pemetrexed in patients with malignant pleural mesothelioma (MPM). Patients and methods Eligible patients had confirmed MPM, ECOG performance status 0–1, and measurable disease. Patients received cisplatin 75 mg/m 2 and pemetrexed 500 mg/m 2 on day 1 and CP-870,893 on day 8 of a 21-day cycle for maximum 6 cycles with up to 6 subsequent cycles single-agent CP-870,893. Immune cell subset changes were examined weekly by flow cytometry. Results Fifteen patients were treated at three dose levels. The MTD of CP-870,893 was 0.15 mg/kg, and was exceeded at 0.2 mg/kg with one grade 4 splenic infarction and one grade 3 confusion and hyponatraemia. Cytokine release syndrome (CRS) occurred in most patients (80%) following CP-870,893. Haematological toxicities were consistent with cisplatin and pemetrexed chemotherapy. Six partial responses (40%) and 9 stable disease (53%) as best response were observed. The median overall survival was 16.5 months; the median progression-free survival was 6.3 months. Three patients survived beyond 30 months. CD19+ B cells decreased over 6 cycles of chemoimmunotherapy ( P 〈 0.001) with a concomitant increase in the proportion of CD27+ memory B cells ( P 〈 0.001) and activated CD86+CD27+ memory B cells ( P 〈 0.001), as an immunopharmacodynamic marker of CD40 activation. Conclusions CP-870,893 with cisplatin and pemetrexed is safe and tolerable at 0.15 mg/kg, although most patients experience CRS. While objective response rates are similar to chemotherapy alone, three patients achieved long-term survival. Australia New Zealand Clinical Trials Registry number ACTRN12609000294257.
    Print ISSN: 0923-7534
    Electronic ISSN: 1569-8041
    Topics: Medicine
    Published by Oxford University Press
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