Seminars in oncology
-
Seminars in oncology · Oct 1996
Randomized Controlled Trial Comparative Study Clinical TrialCyclophosphamide and cisplatin versus paclitaxel and cisplatin: a phase III randomized trial in patients with suboptimal stage III/IV ovarian cancer (from the Gynecologic Oncology Group).
Administration of an alkylating agent plus a platinum coordination complex is standard therapy for advanced epithelial ovarian cancer in the United States. The most commonly used combination is cyclophosphamide/ cisplatin; however, the benefit of this combination in overall survival has not been compelling. We report a prospective comparison of this regimen versus a combination of cisplatin with paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), a new and well-tolerated agent with documented activity in cisplatin-refractory ovarian cancer. ⋯ Progression-free survival was significantly longer (P < .001) with cisplatin/paclitaxel (median, 12.9 v 17.9 months). Overall survival was also significantly longer (P < .001) with cisplatin/paclitaxel (median, 37.5 v 24.4 months). Incorporating paclitaxel into first-line therapy for patients with suboptimally debulked stage III and stage IV ovarian cancer can increase the duration of the progression-free interval and extend overall survival while maintaining an acceptable toxicity profile.
-
Seminars in oncology · Oct 1996
Randomized Controlled Trial Comparative Study Clinical TrialAn ongoing European organization for research and treatment of cancer crossover trial comparing single-agent paclitaxel and doxorubicin as first- and second-line treatment of advanced breast cancer.
The activity of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) in advanced breast cancer patients who have failed doxorubicin treatment is well established, but the optimal sequence between these two important agents remains to be determined. The European Organization for Research and Treatment of Cancer therefore designed a prospective randomized clinical trial in which patients not exposed to anthracyclines in the adjuvant setting received either first-line paclitaxel, given as a 3-hour infusion at a dose of 200 mg/m2 followed at the time of disease progression by second-line doxorubicin, given as a bolus injection at a dose of 75 mg/m2 or the reverse sequence. The target accrual is 330 patients. Interim results on 207 evaluable patients of 289 randomized are presented.
-
Seminars in oncology · Aug 1995
Randomized Controlled Trial Comparative Study Clinical TrialDose-finding and sequencing study of paclitaxel and carboplatin in non-small cell lung cancer.
A dose-finding study was set up to identify the optimal dose of the combination of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and carboplatin for phase II studies in patients with advanced chemotherapy-naive non-small cell lung cancer (NSCLC). The influence of drug sequence on the toxicity and pharmacokinetics of both agents was also assessed. To develop an ambulatory regimen for palliation of advanced NSCLC, paclitaxel was infused over 3 hours with standard premedication and carboplatin over 30 minutes. ⋯ At the highest paclitaxel dose (250 mg/m2 with carboplatin 350 mg/m2) a toxic death due to severe leukopenia, thrombocytopenia, and hemorrhage occurred. Safe doses for phase II trials in untreated NSCLC are 200 mg/m2 paclitaxel with 300 mg/m2 carboplatin. Of 50 evaluable patients, five of the six major responses were observed at paclitaxel doses of 175 mg/m2 and above, which suggests a dose-response relationship for paclitaxel in NSCLC.
-
Seminars in oncology · Jun 1995
Randomized Controlled Trial Comparative Study Clinical TrialOne-hour paclitaxel infusion schedules: a phase I/II comparative trial.
The safety and feasibility of two 1-hour outpatient paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) infusion schedules were evaluated in a randomized phase I/II study of 56 patients with a variety of resistant and refractory advanced cancers. Paclitaxel 135 mg/m2 was infused as a single dose over 1 hour or was divided into three doses infused over 1 hour on 3 consecutive days. Standard paclitaxel premedications were given. ⋯ Neutropenic fever necessitated nine hospitalizations (eight patients.) Preliminary findings show objective responses in 11 patients (20%). Responders had breast, ovarian, and lung cancers. We conclude that both 1-hour paclitaxel outpatient infusion schedules are safe, and we are currently investigating a 200 mg/m2 dose and the incorporation of the 135 mg/m2 schedules into phase II combination chemotherapy regimens.
-
Seminars in oncology · Oct 1994
Randomized Controlled Trial Clinical TrialA phase II study of cisplatin, 5-fluorouracil, and leucovorin augmented by vinorelbine (Navelbine) for advanced non-small cell lung cancer: rationale and study design.
In a randomized phase II study by the Cancer and Leukemia Group B, the cisplatin/5-fluorouracil/leucovorin (PFL) combination produced a 29% response rate in advanced, unresectable non-small cell lung cancer. Vinorelbine (Navelbine; Burroughs Wellcome, Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France), a semisynthetic vinca alkaloid, has also demonstrated single-agent activity in this disease. Therefore, a phase I-II study was designed to investigate the addition of vinorelbine in escalating doses to the PFL combination. ⋯ It was concluded that this dose level was not feasible. During a preliminary analysis, one complete response and three partial responses were observed in 16 patients evaluated; one of these patients had a pathologic complete remission. This early analysis indicates activity for the regimen.