Seminars in oncology
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Seminars in oncology · Feb 1997
Multicenter Study Clinical TrialPaclitaxel in simultaneous radiochemotherapy of head and neck cancer: preclinical and clinical results.
Several studies have presented evidence that paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) displays a radiation-sensitizing effect. We therefore analyzed the influence of paclitaxel and concomitant radiation on the proliferation kinetics of head and neck tumor cells and normal fibroblasts. Our data clearly support the notion that paclitaxel given with radiation exerts an additive effect on the clonogenic survival of squamous cell carcinoma cells and normal fibroblasts. ⋯ Paclitaxel is given on a one-time weekly basis. Up to now, 13 evaluable patients have been treated, and the maximum tolerable dose has not been reached at 40 mg/m2. Mucositis is expected to be the dose-limiting toxicity.
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Seminars in oncology · Feb 1997
ReviewTopotecan and the treatment of recurrent ovarian cancer: is there a role for granulocyte colony-stimulating factor?
Topotecan (Hycamtin; SmithKline Beecham Pharmaceuticals, Philadelphia, PA) a new chemotherapeutic agent for the treatment of patients with advanced carcinoma of the ovary after failure of initial or subsequent therapy, is a specific, potent inhibitor of the enzyme topoisomerase I. Myelosuppression is the dose-limiting toxicity of topotecan, and can interfere with the administration of the recommended dose/schedule of the drug by delaying the next cycle of chemotherapy or by requiring a reduction in the dose. The results from clinical studies suggest that routine granulocyte colony-stimulating factor therapy is not needed when topotecan is administered at the recommended dose of 1.5 mg/m2/d for 5 days. However, patients should be carefully monitored, as some may benefit from hematopoietic growth factor support on subsequent cycles.
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Seminars in oncology · Feb 1997
Clinical TrialStudy of escalating doses of paclitaxel plus cisplatin in patients with inoperable head and neck cancer.
This phase I/II study sought to determine the response rate and toxicity profile of escalating doses of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) when administered with fixed doses of cisplatin with granulocyte colony-stimulating factor support in 28 patients with head or neck cancer. The study was designed as a modified dose-finding trial and contained five dose-escalation levels of paclitaxel. Dose level 1 contained seven patients, and doses ranged from 175 to 220 mg/m2; dose level 2, 230 to 250 mg/m2 (five patients); dose level 3, 250 mg/m2 only (four patients); dose level 4, 260 to 280 mg/m2 (six patients); and dose level 5, 280 to 300 mg/m2 (six patients). ⋯ No dose-limiting hematologic toxicity was observed, nor was any significant neutropenia seen in those patients receiving filgrastim. The paclitaxel/cisplatin combination was found to be an effective first-line regimen for patients with head or neck cancer. Although the number of patients in this study was small, no relationship was noted between patient response and disease site.
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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.
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Seminars in oncology · Dec 1996
Clinical TrialPaclitaxel plus carboplatin in the treatment of patients with advanced lung cancer: a Vanderbilt University Cancer Center phase II trial (LUN-46).
In studies conducted by the Eastern Cooperative Oncology Group, treatment with either paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) or carboplatin was associated with an improvement in 1-year survival in patients with stage IV non-small cell lung cancer (NSCLC). Based on these findings, a phase II trial of carboplatin plus paclitaxel was conducted in patients with advanced NSCLC to determine the activity and toxicity of this regimen. Eligibility requirements included stage IIIB or IV histologically confirmed NSCLC, Eastern Cooperative Oncology Group performance status of 0 to 2, no prior chemotherapy, and adequate hematologic, renal, hepatic, and cardiac functions. ⋯ Median survival was 38 weeks and the survival rate at 1 year was 32%. Paclitaxel plus carboplatin, as given in this study, was found to be a moderately active regimen in patients with advanced NSCLC. This regimen warrants comparison with existing cisplatin-based regimens in a prospective randomized trial.