Seminars in oncology
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Seminars in oncology · Dec 1996
Clinical TrialPhase I/II trial of weekly paclitaxel in patients with advanced lung cancer.
During previous phase I experience of weekly paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) used as a radiation sensitizer, decreased hematologic toxicity was noted. Therefore, an extended phase I/II trial of weekly paclitaxel in patients with chemotherapy-naive, metastatic non-small cell lung cancer was conducted to determine the maximum tolerated dose and activity of this alternative schedule. Twenty-six patients entered this study through six dose levels of paclitaxel (100, 125, 135, 150, 175, and 200 mg/m2/wk) administered weekly for 6 of 8 weeks. ⋯ Nine of 24 patients (38%) demonstrated objective responses. We conclude that the maximum tolerated dose of weekly paclitaxel administered for 6 weeks in an 8-week cycle is 175 mg/m2/wk. The response rate is encouraging and this schedule merits further investigation.
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Seminars in oncology · Dec 1996
Paclitaxel and simultaneous radiation in the treatment of stage IIIA/B non-small cell lung cancer.
In a clinical phase II trial, escalating doses of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) were given with concurrent radiation to patients with stage IIIA/B non-small cell lung cancer. Radiotherapy was given in daily doses of 2 Gy, 5 days a week, in weeks 1 through 3 and 6 through 8. Paclitaxel was given on day 1 of weeks 1 through 3 and 6 through 8, at a starting dose level of 50 mg/m2. ⋯ The overall response rate was 75%. In summary, the maximum tolerated dose of paclitaxel in this study has been determined to be 86 mg/m2 weekly. Pulmonary infections represent the major clinical toxicity, and the high response rate merits further clinical evaluation of this regimen.
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Seminars in oncology · Dec 1996
Clinical TrialPaclitaxel and carboplatin in inoperable non-small cell lung cancer.
Based on the activity of single-agent paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and the significant 1-year survival rates of patients with non-small cell lung cancer treated with carboplatin, the Hellenic Cooperative Oncology Group initiated a phase II trial using both agents in patients with inoperable stage III or IV disease to investigate the efficacy and toxicity of the combination. Since July 1995, 31 patients fulfilling all eligibility criteria entered this study. All patients received paclitaxel 175 mg/m2 as a 3-hour infusion and carboplatin dosed to an area under the concentration-time curve of 7, every 3 weeks. ⋯ Grade 2/3 neutropenia occurred in 11.1% of patients, whereas grade 2 thrombocytopenia was seen in only 3.7%. One patient died following complications of severe allergic reaction. In conclusion, although this study is ongoing, combination treatment using paclitaxel and carboplatin is both effective and well tolerated in patients with inoperable non-small cell lung cancer.
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Seminars in oncology · Dec 1996
Paclitaxel and radiotherapy in the treatment of advanced non-small cell lung cancer.
Sixteen patients affected by previously untreated non-small cell lung cancer stage IIIB or IV received radiotherapy and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) as radiation sensitizer in an open, nonrandomized pilot study to find the maximum tolerated dose of the drug concomitantly combined with radiation. Paclitaxel was given as a 3-hour infusion once weekly at a dose escalating by 10 mg/m2/wk for every patient cohort, starting at 40 mg/m2/wk and continuing to 80 mg/m2/wk. Conventionally fractionated (2 Gy/d for 5 d/wk for 5 weeks) radiotherapy up to 50 Gy was delivered to the primary tumor and mediastinum with a 6-mv linear accelerator. ⋯ Paclitaxel may be safely combined with radiation at the maximum tolerated dose of 70 mg/m2/wk. Our data seem to confirm the radiosensitizing effect of the drug, independent of the dose level. Low doses of paclitaxel given as a single agent are unable to control metastatic disease.
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Seminars in oncology · Oct 1996
Clinical TrialPaclitaxel in the treatment of patients with upper gastrointestinal carcinomas.
New agents active against unresectable metastatic and locoregional carcinoma of the esophagus or stomach are needed to improve patient outcomes. Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) appears to be active against both adenocarcinoma and squamous cell carcinoma of the esophagus. A phase II study of paclitaxel 250 mg/m2 administered by 24-hour intravenous infusion every 21 days with granulocyte colony-stimulating factor (5 micrograms/kg/d subcutaneously 24 hours following paclitaxel) was conducted in such patients who had received no prior chemotherapy or biologic therapy. ⋯ Anderson Cancer Center exploring the single-agent activity of paclitaxel 200 mg/m2 every 21 days without routine granulocyte colony-stimulating factor in previously untreated patients suggest definite, albeit low-level, activity against gastric carcinoma. Only one PR and three minor responses occurred among the first 15 patients who received paclitaxel in a 3-hour infusion. When the paclitaxel infusion was extended to 24 hours in this ongoing trial, three of the next 10 evaluable patients achieved a PR, with toxicity similar to that observed in other trials of paclitaxel at this dose range.