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  • 1
    Electronic Resource
    Electronic Resource
    A phase II study of the modulation of 5-fluorouracil and folinic acid with high-dose infusional hydroxyurea in metastatic colorectal carcinoma (1999)
    Springer
    Annals of oncology 10 (1999), S. 981-983 
    Details
    ISSN: 1569-8041
    Keywords: chemotherapy ; colorectal cancer ; 5-fluorouracil ; folinic acid ; hydroxyurea ; modulation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: Hydroxyurea (HU), an inhibitor of ribonucleotide reductase, may potentiate the activity of 5-fluorouracil (5-FU) and folinic acid (FA) by reducing the deoxyribonucleotide pool available for DNA synthesis and repair. However as HU may inhibit the formation of 5-fluoro-2′-deoxyuridine-5′-monophosphate (FdUMP), one of the principal active metabolites of 5-FU, the scheduling of HU may be critical. In vitro experiments suggest that administration of HU following 5-FU, maintaining the concentration in the region of 1 mM for six or more hours, significantly enhances the efficacy of 5-FU. Patients and methods: 5-FU/FA was given as follows: days 1 and 2 – FA 250 mg/m2 (max. 350 mg) over two hours followed by 5-FU 400 mg/m2 by intravenous bolus (ivb) over 15 minutes and subsequently 5-FU 400 mg/m2 infusion (ivi) over 22 hours. HU was administered on day 3 immediately after the 5-FU with 3 g ivb over 15 minutes followed by 12 g ivi over 12 hours. Results: Thirty patients were entered into the study. Median survival was nine months (range 1–51+ months). There were eight partial responses (28%, 95% CI: 13%–47%). The median duration of response was 6.5 (range 4–9 months). Grade 3–4 toxicities included neutropenia (grade 3 in eight patients and grade 4 in five), anaemia (grade 3 in one patient) and diarrhoea (grade 3 in two patients). Neutropenia was associated with pyrexia in two patients. Phlebitis at the infusion site occurred in five patients. The treatment was complicated by pulmonary embolism in one patient and deep venous thrombosis in another. Conclusion: HU administered in this schedule is well tolerated. Based on these results and those of other phase II studies, a randomised phase III study of 5-FU, FA and HU versus 5-FU and FA using the standard de Gramont schedule is recommended.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008330302535
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  • 2
    Electronic Resource
    Electronic Resource
    The systemic treatment of non-small-cell lung cancer (1997)
    Springer
    Annals of oncology 8 (1997), S. 285-290 
    Details
    ISSN: 1569-8041
    Keywords: chemotherapy ; lung cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008243426968
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  • 3
    Electronic Resource
    Electronic Resource
    Phase I trial of the selective mitochondrial toxin MKT 077 in chemo-resistant solid tumours (1999)
    Springer
    Annals of oncology 10 (1999), S. 923-927 
    Details
    ISSN: 1569-8041
    Keywords: mitochondrial toxin ; MKT 077 ; phase I trial
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: MKT 077 is a rhodacyanine dye analogue which preferentially accumulates in tumour cell mitochondria. It is cytotoxic to a range of tumours. In this phase I study, MKT 077 was administered as a five-day infusion once every three weeks. Patients and methods: Ten patients, median age 59 (38–70) years, with advanced solid cancers were treated at three dose levels: 30, 40 and 50 mg/m2/day for a total of 18 cycles.31 Phosphorus magnetic resonance spectroscopy (MRS) was used to evaluate the effect of MKT 077 on skeletal muscle mitochondrial function. Results: The predominant toxicity was recurrent reversible functional renal impairment (grade 2, two patients). One patient with renal cancer attained stable disease and the remainder progressive disease. There were no MRS changes in the first or second treatment cycles but one patient received 11 treatment cycles and developed changes consistent with a mitochondrial myopathy. Mean values for all pharmacokinetic parameters were at sub micromolar levels and did not exceed IC50 values (≥1 µM). Conclusions: Because of the renal toxicity, and animal studies showing MKT 077 causes eventual irreversible renal toxicity, further recruitment was halted. The study shows, however, that it is feasible to target mitochondria with rhodacyanine analogues, if drugs with higher therapeutic indices could be developed.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008336904585
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  • 4
    Electronic Resource
    Electronic Resource
    A phase II study of mitomycin C and oral etoposide for advanced adenocarcinoma of the upper gastrointestinal tract (1997)
    Springer
    Annals of oncology 8 (1997), S. 294-296 
    Details
    ISSN: 1569-8041
    Keywords: advanced gastric cancer ; mitomycin C ; oral etoposide
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: Mitomycin C and etoposide have both demonstrated activityagainst gastric carcinoma. Etoposide is a topoisomerase II inhibitor withevidence for phase-specific and schedule-dependent activity. Patients and method: Twenty-eight consecutive patients with advancedupper gastrointestinal adenocarcinoma were treated with intravenous (i.v.)bolus mitomycin C 6 mg/m2 on day 1 every 21 days to a maximumof four courses. Oral etoposide capsules 50 mg b.i.d. (or 35 mg b.i.d. liquid)were administered days 1 to 10 extending to 14 days in subsequent courses ifabsolute neutrophil count 〉1.5 × 109/l on day 14 offirst course, for up to six courses. Results: Twenty-six patients were assessed for response of whom 12had measurable disease and 14 evaluable disease. Four patients had adocumented response (one complete remission, three partial remissions) withan objective response rate of 15% (95% confidence interval(95% CI) 4%–35%). Eight patients had stable diseaseand 14 progressive disease. The median survival was six months. The schedulewas well tolerated with no treatment-related deaths. Nine patients experiencedleucopenia (seven grade II and two grade III). Nausea and vomiting (eightgrade II, one grade III), fatigue (eight grade II, two grade III) and anaemia(seven grade II, two grade III) were the predominant toxicities. Conclusion: This out-patient schedule is well tolerated and showsmodest activity in the treatment of advanced upper gastrointestinaladenocarcinoma. Further studies using protracted schedules of etoposide bothorally and as infusional treatment should be developed.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008295926603
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