Seminars in oncology
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Seminars in oncology · Feb 1997
ReviewTopotecan and the treatment of recurrent ovarian cancer: is there a role for granulocyte colony-stimulating factor?
Topotecan (Hycamtin; SmithKline Beecham Pharmaceuticals, Philadelphia, PA) a new chemotherapeutic agent for the treatment of patients with advanced carcinoma of the ovary after failure of initial or subsequent therapy, is a specific, potent inhibitor of the enzyme topoisomerase I. Myelosuppression is the dose-limiting toxicity of topotecan, and can interfere with the administration of the recommended dose/schedule of the drug by delaying the next cycle of chemotherapy or by requiring a reduction in the dose. The results from clinical studies suggest that routine granulocyte colony-stimulating factor therapy is not needed when topotecan is administered at the recommended dose of 1.5 mg/m2/d for 5 days. However, patients should be carefully monitored, as some may benefit from hematopoietic growth factor support on subsequent cycles.
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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.