Seminars in oncology
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Seminars in oncology · Feb 1997
Clinical TrialIntensive radiation therapy concurrent with up to 7-week continuous-infusion paclitaxel for locally advanced solid tumors: phase I studies.
Patients with locally advanced solid tumors of the lung, head and neck, and malignant astrocytomas usually succumb to their disease despite aggressive standard therapy. Laboratory data suggest that the addition of 1.0 to 10 nmol/L paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), a microtubule stabilizing drug, to radiation therapy may result in significant radiation sensitization, perhaps due to accumulation of cells at G2/M. Relatively low concentrations (1.0 to 10 nmol/L) appear to be optimal for direct cytotoxicity and radiosensitization in vitro. ⋯ The ultimate goal of this study is to improve local and systemic control and survival for patients with these three tumor types. To date, 39 evaluable patients are enrolled in this study; there has been no dose-limiting toxicity up to 6.5 mg/m2/d. Observed toxicities include anemia, lymphopenia, mucositis, and cutaneous toxicities.
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Seminars in oncology · Feb 1997
Clinical TrialPhase I studies of combined paclitaxel/epirubicin and paclitaxel/epirubicin/cyclophosphamide in patients with metastatic offast cancer: the French experience.
In an attempt to develop new, active, and convenient outpatient combination-chemotherapy regimens for patients with metastatic breast cancer, we performed two phase I studies combining paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) plus anthracycline for the first-line treatment of metastatic disease, without the use of hematopoietic growth factors. Study I was designed to test the tolerability and antitumor activity of a 3-hour infusion of paclitaxel in combination with an epirubicin intravenous bolus. Study 2 explored a three-drug chemotherapy regimen: a 3-hour paclitaxel infusion with epirubicin and cyclophosphamide. ⋯ The dose-limiting toxicity has not been reached, and we are currently investigating dose level 4 (paclitaxel 225 mg/m2). These trials confirm the tolerability of combined paclitaxel/epirubicin and paclitaxel/epirubicin/cyclophosphamide. The antitumor activity is encouraging.
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Seminars in oncology · Feb 1997
Clinical TrialStudy of escalating doses of paclitaxel plus cisplatin in patients with inoperable head and neck cancer.
This phase I/II study sought to determine the response rate and toxicity profile of escalating doses of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) when administered with fixed doses of cisplatin with granulocyte colony-stimulating factor support in 28 patients with head or neck cancer. The study was designed as a modified dose-finding trial and contained five dose-escalation levels of paclitaxel. Dose level 1 contained seven patients, and doses ranged from 175 to 220 mg/m2; dose level 2, 230 to 250 mg/m2 (five patients); dose level 3, 250 mg/m2 only (four patients); dose level 4, 260 to 280 mg/m2 (six patients); and dose level 5, 280 to 300 mg/m2 (six patients). ⋯ No dose-limiting hematologic toxicity was observed, nor was any significant neutropenia seen in those patients receiving filgrastim. The paclitaxel/cisplatin combination was found to be an effective first-line regimen for patients with head or neck cancer. Although the number of patients in this study was small, no relationship was noted between patient response and disease site.
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Seminars in oncology · Dec 1996
Randomized Controlled Trial Clinical TrialOne-hour paclitaxel in the treatment of non-small cell lung cancer.
This review describes studies with two paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ)-containing treatments for non-small cell lung cancer (NSCLC). In an ongoing study, 100 patients with previously untreated stage IIIB or IV NSCLC received combination therapy comprised of paclitaxel 225 mg/m2 via 1-hour infusion and carboplatin, dosed to an area under the concentration-time curve of 6.0. Both drugs were given intravenously and cycles were repeated every 21 days. ⋯ Grade 3/4 esophagitis was observed in 51% of participants and usually occurred during the final 2 weeks of combined-modality therapy. The combination of paclitaxel and carboplatin is active and well tolerated in patients with advanced NSCLC, and paclitaxel-based combined-modality therapy produced a high rate of complete and partial responses and encouraging survival data. Continued investigation and refinement of these regimens is ongoing.
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Seminars in oncology · Dec 1996
Clinical TrialPaclitaxel plus carboplatin in the treatment of patients with advanced lung cancer: a Vanderbilt University Cancer Center phase II trial (LUN-46).
In studies conducted by the Eastern Cooperative Oncology Group, treatment with either paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) or carboplatin was associated with an improvement in 1-year survival in patients with stage IV non-small cell lung cancer (NSCLC). Based on these findings, a phase II trial of carboplatin plus paclitaxel was conducted in patients with advanced NSCLC to determine the activity and toxicity of this regimen. Eligibility requirements included stage IIIB or IV histologically confirmed NSCLC, Eastern Cooperative Oncology Group performance status of 0 to 2, no prior chemotherapy, and adequate hematologic, renal, hepatic, and cardiac functions. ⋯ Median survival was 38 weeks and the survival rate at 1 year was 32%. Paclitaxel plus carboplatin, as given in this study, was found to be a moderately active regimen in patients with advanced NSCLC. This regimen warrants comparison with existing cisplatin-based regimens in a prospective randomized trial.