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  • phase I study  (1)
  • phase II  (1)
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  • 1
    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
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  • 2
    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
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