YOU ARE NOW CONNECTED TO THE TOXLINE (1981 FORWARD, NON-ROYALTY) FILE. ==LUNG NEOPLASMS AND TAXOTERE== 3 AUTHOR Francis PA AUTHOR Kris MG AUTHOR Rigas JR AUTHOR Grant SC AUTHOR Miller VA TITLE Paclitaxel (Taxol) and docetaxel (Taxotere): active chemotherapeutic agents in lung cancer. SOURCE Lung Cancer; VOL 12 Suppl 1, 1995, PS163-72 (REF: 40) ABSTRACT Paclitaxel (Taxol), the prototype of a new class of plant-derived antineoplastic compounds, is a natural product isolated from the Pacific yew. Docetaxel (Taxotere) is a hemisynthetic product derived from the European yew. These agents share a unique mechanism of cytotoxic action by promoting assembly of microtubules and rendering the microtubules resistant to depolymerization. In vitro studies suggest a possible role for radiation sensitization. In Phase I trials, the dose-limiting toxicity was neutropenia for both agents. Other toxicities include infusion-related hypersensitivity reactions, alopecia, neurotoxicity, mucositis, diarrhoea and myalgias. To prevent infusion-related reactions, routine premedication is recommended. Noncumulative cardiac toxicity has been observed with paclitaxel. Fluid retention and rash have been reported with docetaxel. In Phase II studies of paclitaxel in advanced non-small cell lung cancer, response rates of 21% and 24% were observed. In Phase II studies of docetaxel in similar patients, response rates ranging from 28-38% were reported, including patients previously treated with cisplatin. The most common toxicity in these studies was neutropenia. Combination studies with cisplatin and other agents are in progress. Paclitaxel and docetaxel are among the most active chemotherapeutic agents for non-small cell lung cancer patients. Their testing will dominate trials of new therapies in this disease for years to come. 6 AUTHOR Fossella FV AUTHOR Lee JS AUTHOR Berille J AUTHOR Hong WK TITLE Summary of phase II data of docetaxel (Taxotere), an active agent in the first- and second-line treatment of advanced non-small cell lung cancer. SOURCE Semin Oncol; VOL 22, ISS 2 Suppl 4, 1995, P22-9 (REF: 37) ABSTRACT Six phase II studies have been conducted in the United States and Europe using docetaxel (Taxotere; Rhone-Poulenc Rorer, Antony, France) for advanced non-small cell lung cancer. One hundred eighty chemotherapy-naive patients in four studies and 88 patients who failed prior platinum-containing chemotherapy in two studies were treated with docetaxel 75 to 100 mg/m2 intravenously over 1 hour every 3 weeks. Fifty-nine percent of patients had adenocarcinoma and 82% had stage IV disease. At a dose of 100 mg/m2, 30% of evaluable chemotherapy-naive patients (27% of the intent-to-treat population) and 20% of evaluable platinum-refractory/resistant patients (17% of the intent-to-treat population) achieved a partial response; projected median survival is 9 months in both studies. Neutropenia was the primary dose-limiting acute side effect. Fluid retention, which occurred in patients who received multiple courses of treatment, was common but rarely dose-limiting, and may be ameliorated with prophylactic corticosteroids. Other toxic effects were relatively mild. Docetaxel has significant activity against advanced non-small cell lung cancer, producing a major response in both chemotherapy-naive patients and patients who had failed prior platinum-containing chemotherapy. 7 AUTHOR Taylor SA TITLE Evaluation of Taxotere in Small Cell Lung Carcinoma, Phase II (SWOG-9242) SOURCE FEDRIP DATABASE, NATIONAL TECHNICAL INFORMATION SERVICE (NTIS) ABSTRACT RPROJ/FEDRIP LUNG NEOPLASMS; EVALUATION STUDIES; CLINICAL TRIALS, PHASE II; CARCINOMA, SMALL CELL OBJECTIVES: To evaluate the efficacy, as measured by the response rate, of Taxotere given every three weeks by IV infusion to patients with previously untreated extension small cell lung cancer. To assess the clinical and laboratory toxicities as well as patient tolerance of this dose/schedule of intravenous Taxotere. RESEARCH PLAN: All patients will initially receive the same treatment, repeated every 3 weeks. Prior to each Taxotere infusion, patients should be premedicated with diphenhydramine, cimetidine and dexamethasone as outlined in the treatment plan. Responding or stable disease patients will continue on study until tumor progression. RESULTS TO DATE: This study has accrued 21 patients to date. One patient died of a respiratory infection associated with bilateral pneumothorax and one died of a pulmonary embolism. Ten patients have had Grade 4 toxicities, primarily myelosuppression.