Seminars in oncology
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Seminars in oncology · Dec 1996
Review Clinical TrialPaclitaxel via 1-hour infusion: clinical experience.
In phase II trials, paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) can be safely administered via a 1-hour infusion. One-hour infusions of paclitaxel also have been administered safely in combination with many other cytotoxic regimens, including cisplatin/etoposide/radiation, carboplatin/etoposide (with or without radiation), mitoxantrone/5-fluorouracil/leucovorin, carboplatin, and carboplatin/5-fluorouracil. Notable activity has been seen in patients with several neoplasms, including stages III/IV non-small cell lung cancer, small cell lung cancer, advanced breast cancer, carcinoma of unknown primary site, urothelial carcinomas, and other advanced squamous cell carcinomas. Further study will determine whether these or similar combinations represent improved therapeutic alternatives.
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Seminars in oncology · Dec 1996
Randomized Controlled Trial Clinical TrialPaclitaxel and carboplatin as neoadjuvant chemotherapy in operable (stage I and II) and locally advanced (stage IIIA-N2) non-small cell lung cancer.
In 1995, a randomized intergroup study of neoadjuvant chemotherapy followed by either surgery or radiotherapy in the treatment of non-small cell lung cancer was started under the auspices of the European Organization for Research and Treatment of Cancer (EORTC 08941). The objective of this study is to investigate whether surgery or radiotherapy represents superior locoregional treatment, in terms of survival and quality of life, for patients with stage IIIA(N2) non-small cell lung cancer who have achieved a response after three courses of neoadjuvant chemotherapy. A phase II side study will investigate the clinical and pathologic response rate (if applicable), as well as acute and late side effects during or after consecutive surgery and/or radiotherapy of combination paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and carboplatin. ⋯ Depending on the response rate and early and late side effects observed in this well-defined, prognostically favorable group of patients, it will be decided whether and how to use the same combination chemotherapy in an ongoing randomized trial currently being conducted by the Dutch Lung Cancer Study Group (DLCSG 94-2). In the latter trial, patients with stage I and II non-small cell lung cancer are randomized to immediate surgery or two courses of neoadjuvant chemotherapy. Responding patients will receive another two courses of chemotherapy before surgery; nonresponders will go directly to surgery.
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Seminars in oncology · Dec 1996
Clinical Trial Controlled Clinical TrialPaclitaxel and simultaneous radiation in locally advanced stage IIIA/B non-small cell lung cancer: a clinical phase I study.
Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) is one of the most active single agents for the treatment of non-small cell lung cancer, with response rates of 21% to 24%. We present a phase I study with paclitaxel and simultaneous radiation in previously untreated, locally advanced, inoperable, stage IIIA/B non-small cell lung cancer. The aims of the study were to determine the maximum tolerated dose, define the safety and toxicity, and obtain preliminary data about the activity of the combined modality. ⋯ Importantly, no severe adverse events were observed that could be associated with paclitaxel or radiotherapy. This combined modality appears to be a practicable and effective treatment of non-small cell lung cancer. The maximum tolerated dose has not yet been reached, and dose escalation is planned.
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Seminars in oncology · Dec 1996
Clinical TrialPhase I study of cisplatin, etoposide, and paclitaxel in patients with extensive-stage small cell lung cancer: a University of Colorado Cancer Center study.
This phase I study investigated the maximum tolerated dose of cisplatin, etoposide, and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) in 18 patients with advanced small cell lung cancer. Cisplatin (80 mg/m2) and etoposide (50 or 80 mg/m2 intravenously and 100 or 160 mg/m2 orally) were infused concomitantly 30 minutes after a 3-hour infusion of paclitaxel (135, 175, or 200 mg/m2). This order of administration was known to cause less toxicity than the reverse order. ⋯ Thus, we expect to recommend the following dosages for further study: cisplatin 80 mg/m2, etoposide 80 mg/m2, and paclitaxel 175 mg/m2. All patients had an objective response and one third had a complete response, compared with 10% of patients in most series. We conclude that paclitaxel can be added safely to full doses of cisplatin and etoposide with encouraging efficacy, and recommend a randomized trial be undertaken to compare the two-drug regimen with the three-drug regimen.
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Seminars in oncology · Dec 1996
Clinical TrialPaclitaxel and carboplatin: a phase I study in advanced non-small cell lung cancer.
In the treatment of non-small cell lung cancer paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has significant activity and carboplatin has single-agent activity comparable with that of cisplatin, with less pronounced nonhematologic toxicity. The optimal doses of paclitaxel and carboplatin in combination have not been determined. We designed a phase I study combining a fixed paclitaxel dose of 175 mg/m2, administered either by 3- or 1-hour infusion, with escalating doses of carboplatin given every 4 weeks. ⋯ Six partial responses (31%; 95% confidence interval, 13% to 57%), five (26%) stable diseases, and eight (42%) disease progressions were observed. No additional side effects were observed with the 1-hour paclitaxel infusion and single-dose steroid premedication 1 hour before chemotherapy. The study will continue until the paclitaxel/carboplatin maximum tolerated dose is reached.