Seminars in oncology
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Seminars in oncology · Oct 1997
Multicenter Study Clinical TrialEfficacy and safety of the combination paclitaxel/carboplatin in patients with previously treated advanced ovarian carcinoma: a multicenter French Groupe des Investigateurs Nationaux pour l'Etude des Cancers Ovariens phase II study.
The French Groupe des Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) conducted a multicenter phase II study of carboplatin and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) to evaluate the efficacy and side effects of this combination in pretreated advanced ovarian cancer. Patients with progressive ovarian carcinoma during or after platinum-based chemotherapy received paclitaxel 175 mg/m2 intravenously over 3 hours followed by intravenous carboplatin over 30 minutes every 4 weeks. The dose of carboplatin was calculated using a projected area under the concentration-time curve of 5 mg/mL x min. ⋯ Transitory peripheral neuropathy was present in 45% of patients but was severe in only one patient. One early death was observed due to progressive disease and possibly to therapy. The combination of paclitaxel 175 mg/m2 as a 3-hour infusion and carboplatin dosed to an area under the concentration-time curve of 5 is an effective therapy in patients previously treated with platinum-based chemotherapy and may be administered safely to outpatients who relapse after one or two lines of chemotherapy.
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Seminars in oncology · Oct 1997
Randomized Controlled Trial Multicenter Study Clinical TrialICON 2 and ICON 3 data in previously untreated ovarian cancer: results to date.
The second International Collaborative Ovarian Neoplasm study (ICON 2), was a large, international randomized study of cyclophosphamide/doxorubicin/cisplatin (CAP) versus single-agent carboplatin in patients with previously untreated ovarian cancer. Patients in the CAP arm received 500 mg/m2 cyclophosphamide, 50 mg/m2 doxorubicin, and 50 mg/m2 cisplatin. Carboplatin was dosed to an area under the concentration-time curve of 5. ⋯ In all, 1,070 patients have been entered to date. At the first planned interim analysis, in April 1996 in 434 patients, it was too early to provide efficacy data. The plan was to continue accruing to the trial to a maximum of 2,000 patients, with review in mid-1997, when the events for analysis will be virtually doubled and the data can be interpreted in light of the results of the Intergroup study (European Organization for Research and Treatment of Cancer, the National Cancer Institute of Canada, and the Scottish study) and Gynecologic Oncology Group trial 132.
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Seminars in oncology · Oct 1997
Clinical TrialPhase II study of paclitaxel and epirubicin as first-line therapy in patients with metastatic breast cancer.
Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), the first taxane used in routine clinical practice, has aroused considerable interest for its high single-agent activity against breast cancer and for its novel mechanism of action. Epirubicin, the 4' epimer of doxorubicin, is another agent with a high activity against breast cancer and is known for its lower rate of toxic side effects, especially toxic cardiac events, compared with its mother compound. The combination of paclitaxel and doxorubicin yielded response rates between 63% and 93% in phase I/II studies. ⋯ The median cumulative epirubicin dose was 420 mg/m2 in group A and 630 mg/m2 in group B. The combination of paclitaxel 175 mg/m2 and epirubicin 60 or 90 mg/m2 can be administered safely to patients with metastatic breast cancer. Although response was not the primary end point of this trial, the response data are nonetheless encouraging and suggest that further evaluation of this combination-line treatment of metastatic breast cancer is warranted.
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Seminars in oncology · Aug 1997
Clinical TrialPreliminary results of a phase II study of paclitaxel and cisplatin in patients with non-small cell lung cancer.
Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and cisplatin are cytotoxic drugs active against non-small cell lung cancer (NSCLC) that possess additive cytotoxicity in animal tumors. Paclitaxel and cisplatin are active in patients with advanced NSCLC when given on a 3-weekly schedule. In an attempt to increase activity, we designed a phase II study with a biweekly schedule. ⋯ Median response duration was 31 weeks (range, 9 to 85 weeks). The biweekly schedule of paclitaxel plus cisplatin has noteworthy activity in patients with NSCLC. A relatively large fraction of patients required either dose reduction and/or treatment delay, but World Health Organization grade 3 or 4 toxicity was rare, apart from the neutropenia that caused only a few septicemic episodes.
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Seminars in oncology · Aug 1997
Randomized Controlled Trial Clinical TrialInduction paclitaxel and carboplatin followed by concurrent chemoradiotherapy in patients with unresectable, locally advanced non-small cell lung carcinoma: report of Fox Chase Cancer Center study 94-001.
The paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ)/carboplatin combination has demonstrated promising activity in patients with incurable non-small cell lung cancer (NSCLC). Our exploratory study is designed to evaluate the efficacy of this combination as induction therapy in patients with locally advanced NSCLC, to determine the maximally tolerated doses of paclitaxel and carboplatin administered every 3 weeks during radical thoracic radiation after induction treatment, and to determine the efficacy of granulocyte colony-stimulating factor (G-CSF) priming before induction treatment, followed by conventional G-CSF, compared with conventional G-CSF alone. Eligibility stipulated Karnofsky performance status > or =70%, < or =5% weight loss, and stages IIIB or bulky IIIA NSCLC. ⋯ Induction paclitaxel/carboplatin therapy is active and well tolerated by patients with locally advanced NSCLC. The maximum tolerated doses of paclitaxel and carboplatin during concurrent thoracic radiation and the role of G-CSF priming are not yet established. Severity of esophagitis corresponds to the extent of esophagus irradiated during concurrent thoracic radiotherapy and chemotherapy.