Seminars in oncology
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Seminars in oncology · Jun 1995
ReviewEastern Cooperative Oncology Group studies of paclitaxel and doxorubicin in advanced breast cancer.
Based on their single-agent activity in metastatic breast cancer, paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and doxorubicin have been alternated and combined in Eastern Cooperative Oncology Group studies to identify a tolerable dose and schedule. A pilot trial in patients who had received no more than one prior chemotherapy regimen alternated paclitaxel 200 mg/m2 and doxorubicin 75 mg/m2 every 3 weeks. Seven of 12 patients had objective (complete plus partial) responses. ⋯ This combination has been incorporated as a treatment arm in an ongoing randomized prospective phase III Intergroup trial. By comparing the combination with both drugs as single agents (with crossover to the opposite agent at disease progression), investigators will attempt to assess response, toxicity, and time to progression as well as the degree of cross-resistance between the two agents. Given the poor prognosis of patients with advanced breast cancer, the three arms also will be evaluated in terms of patients' quality of life.
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Seminars in oncology · Jun 1995
ReviewThe role of hematopoietic growth factors in support of ifosfamide/carboplatin/etoposide chemotherapy.
The ifosfamide/carboplatin/etoposide (ICE) combination represents an active chemotherapy regimen across a wide variety of disease types. The most common limiting toxicity for all three of these agents individually and in combination is myelosuppression. Thus, this regimen represents an ideal model to evaluate the role of hematopoietic growth factor support in amelioration of hematologic toxicity, maintenance of dose intensity, and dose escalation. ⋯ The final data analysis is in progress. It is hoped that this trial will define the safety and tolerability of the simultaneous administration of IL-6 and G-CSF following ICE chemotherapy in patients with non-small cell lung cancer. In addition, this trial should determine the biologic activity and hematopoietic recovery observed during the simultaneous administration of these two cytokines in this setting.
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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.
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Seminars in oncology · Jun 1995
Clinical TrialPaclitaxel as a radiation sensitizer in non-small cell lung cancer.
The new anticancer agent paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has demonstrated in vitro radiation-sensitizing effects. In this phase I study, paclitaxel in escalating doses was administered weekly with concurrent radiation therapy to patients with regionally advanced non-small cell lung cancer (NSCLC). The goal was to determine the maximum tolerated dose of paclitaxel in this combination, to identify toxicities, and to evaluate response. ⋯ The combination of concurrent radiation therapy and weekly outpatient paclitaxel can be safely delivered to patients with NSCLC at a dose of 60 mg/m2. Esophagitis appeared to be the dose-limiting toxicity. A phase II study of concurrent paclitaxel and radiation therapy is under way.
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Seminars in oncology · Apr 1995
Clinical TrialDose intensification--a phase I study of ifosfamide with vinorelbine (Navelbine): rationale and study design in advanced non-small cell lung cancer.
A phase I trial of a combination of vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France) and ifosfamide given on a novel schedule on 3 consecutive days with granulocyte colony-stimulating factor was conducted to establish the maximum tolerated dose of vinorelbine and the dose-limiting toxicities of this regimen. Doses of vinorelbine were escalated in cohorts of patients. Of the 29 patients enrolled at the time of data analysis, 26 were evaluable for toxicity. ⋯ The recommended phase II doses were established as 1.6 g/m2/d ifosfamide for 3 days and 30 mg/m2/d vinorelbine for 3 days. This study established that granulocyte colony-stimulating factor was needed for approximately 8 days. We are currently examining the feasibility of two dose levels of vinorelbine (25 mg/m2 and 30 mg/m2/d for 3 days) in combination with ifosfamide (1.6 g/m2/d) given every 2 weeks.