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 Comparative Study Clinical TrialPaclitaxel with carboplatin versus paclitaxel with carboplatin alternating with cisplatin as first-line chemotherapy in advanced epithelial ovarian cancer: preliminary results of a Hellenic Cooperative Oncology Group study.
Ninety previously untreated patients with advanced epithelial ovarian cancer (International Federation of Gynecology and Obstetrics stages IIC, III, and IV) were randomized, after initial cytoreductive surgery, to receive paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) 175 mg/m2 as a 3-hour infusion with either carboplatin at an area under the concentration-time curve of 7 (group A) or carboplatin at an area under the concentration-time curve of 7 on courses 1, 3, and 5, alternating with cisplatin 75 mg/m2 on courses 2, 4, and 6 (group B). Treatment was given every 3 weeks, up to a total of six courses. Sixty-one patients (33 and 28 patients in groups A and B, respectively) had residual disease after the initial cytoreductive surgery. ⋯ Treatment was generally well tolerated. Grade 3 and 4 neutropenia was 20% and 32% for groups A and B, respectively, while grade 3 and 4 thrombocytopenia was 4% and 7%, respectively, with no significant difference between the two groups. In conclusion, both combinations seem very active for the treatment of advanced epithelial ovarian cancer and are associated with acceptable toxicity.
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Seminars in oncology · Oct 1997
Randomized Controlled Trial Comparative Study Clinical TrialCarboplatin/paclitaxel versus cisplatin/paclitaxel as first-line chemotherapy in advanced ovarian cancer: an interim analysis of a randomized phase III trial of the Arbeitsgemeinschaft Gynäkologische Onkologie Ovarian Cancer Study Group.
Since publication of the results of the Gynecologic Oncology Group III study, the combination of cisplatin/paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has been widely adopted as standard treatment for advanced ovarian cancer. Further attempts to optimize first-line chemotherapy with platinum and taxanes include the substitution of cisplatin with carboplatin, individualization of the carboplatin dose by calculating it according to the area under the concentration-time curve, and reduction of paclitaxel infusion duration. These attempts have led to the initiation of several phase I/II trials evaluating the combination of carboplatin/paclitaxel. ⋯ Retrospective comparison reveals no significant difference in response rates between patients in the cisplatin/paclitaxel arm of Gynecologic Oncology Group III and those in the Arbeitsgemeinschaft Gynäkologische Onkologie study. Overall, this interim analysis did not reveal any reason for an early termination of this study. Accrual is ongoing and is expected to be completed this year.
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Seminars in oncology · Oct 1997
Clinical TrialSalvage weekly paclitaxel in recurrent ovarian cancer.
The objectives of this study were to determine the toxicity and phase II dose of weekly paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) administration and to describe our initial experience with salvage weekly intravenous paclitaxel in women with advanced recurrent ovarian carcinoma. We conducted a phase I trial of paclitaxel administered as a 1-hour infusion in advanced ovarian cancer patients, using doses of 40 to 100 mg/m2/wk. As a follow-up study, we retrospectively reviewed the medical records of 45 patients with advanced, recurrent epithelial ovarian cancer treated between January 1, 1996, and October 30, 1996, with single-agent weekly intravenous paclitaxel (60 to 100 mg/m2, 1-hour infusions). ⋯ We conclude that weekly intravenous paclitaxel is an active and well-tolerated regimen in heavily pretreated women with recurrent ovarian carcinoma. Prior therapy with paclitaxel does not preclude response to this regimen. A phase II trial of weekly paclitaxel in paclitaxel-refractory patients is under way.
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Seminars in oncology · Oct 1997
Clinical TrialPhase I trial of paclitaxel, carboplatin, and methotrexate with granulocyte colony-stimulating factor and leucovorin in advanced transitional cell carcinoma.
Advanced transitional cell carcinoma (TCC) of the urothelial tract is usually fatal despite high response rates to platinum-based chemotherapy regimens. Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has demonstrated marked single-agent activity in TCC, and combinations of carboplatin and paclitaxel have been well tolerated in other solid tumors. Methotrexate is also active in TCC. ⋯ One patient has achieved a complete response, seven are partial responders, seven have stable disease, and one progressed on therapy. The overall response rate is 50% (95% confidence interval, 25% to 75%). The combination of paclitaxel, carboplatin, and methotrexate holds promise to be well tolerated and active in advanced TCC.