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At least 307 records · Page 17Linked to original sources

A phase I-II trial of topotecan and gemcitabine in patients with previously treated, advanced non-small cell lung cancer (LOA-3).

The purposes of this study were to determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), toxicity profile, and antitumor activity of topotecan (TOP) and gemcitabine (GEM) combination therapy when administered to patients with previously treated, advanced, non-small cell lung cancer. Both compounds were administered intravenously over 30 min, with TOP on days 1-5 and GEM on days 1 and 5 only. Nineteen patients were treated with 75 courses at three dose levels. The MTD was 0.75 and 400 mg/m2 for TOP and GEM, respectively, with thrombocytopenia and neutropenia as the DLTs. Partial responses were achieved in 3 of 17 patients (18%) with measurable disease. Six patients (32%) had disease stabilization for at least four courses of treatment. The median survival was 10 months from the initiation of TOP and GEM. This combination was relatively well tolerated and exhibited promising antitumor activity in patients with advanced, previously treated, non-small cell lung cancer.

Adult↗

A phase I trial of gemcitabine and infusional 5-fluorouracil (5-FU) in patients with refractory solid tumors: Louisiana Oncology Associates protocol no. 1 (LOA-1).

The major purposes of this study were to determine the maximally tolerated dose (MTD), dose-limiting toxicity (DLT), toxicity profile, and antitumor activity of gemcitabine (GEM) (Gemzar) and 5-fluorouracil (5-FU) combination therapy when administered to patients with advanced solid tumors. GEM was administered intravenously over 30 minutes on days 1, 8, and 15, and 5-FU was administered as a continuous intravenous infusion from day 1 through day 15 of each 28-day treatment course. Seventeen patients (13 men and 4 women, median age 57, all previously treated with chemotherapy) were treated with 68 courses at 3 dose levels: 800/200, 1,000/200, and 1,000/300 [GEM (mg/m2/week)/ 5-FU (mg/m2/day)]. Two further patients were not fully evaluable for toxicity; one died from a probable pulmonary embolism, and one refused further treatment after developing grade II mucositis and dermatitis after her day 1 to 7 treatment. At the third dose level, 2 of 4 patients developed grade III mucositis; one also developed grade IV neutropenia with fever and grade III thrombocytopenia. Patient accrual then resumed at the second dose level. At this level, 10 patients were treated, with two developing grade III mucositis. One of these patients also developed grade IV dermatitis. No other patient developed grade III or IV side effects. Prophylactic dexamethasone was initiated after 4 of the first 7 patients (including 1 of the not fully evaluable patients) developed dermatitis-grade IV in 1 patient and grade II in the remaining 3 patients. After the steroids were initiated, 4 of the last 11 patients treated developed dermatitis, but grade 1 in all cases. One patient with metastatic gastric cancer achieved a near-complete response of his gastric mass and adrenal metastasis. Minor responses were achieved in a patient with colon carcinoma and a patient with an ethmoid sinus adenoid cystic carcinoma. The MTD and recommended dose for phase II clinical trials of GEM and 5-FU on the above schedule is 1,000 mg/m2 and 200 mg/m2 respectively, with mucositis as the DLT.

Adult↗

Phase I trial of gemcitabine, administered as a standard and constant dose-rate infusion, in combination with paclitaxel in patients with advanced solid tumors (LOA-2).

The major purposes of this study were to determine the maximally tolerated dose (MTD), dose-limiting toxicity (DLT), toxicity profile, and antitumor activity of gemcitabine and paclitaxel combination therapy when administered to patients with advanced solid tumors, using two infusion schedules of each agent. Paclitaxel was administered on day 1, followed by gemcitabine, and gemcitabine alone was administered on day 8, of each 21-day treatment course. In the initial phase of the trial, paclitaxel was administered during 3 hours and gemcitabine during 30 minutes (schedule A). After the MTD was determined on this schedule, patients were then treated with paclitaxel during 1 hour and gemcitabine at a fixed dose-rate of 10 mg/m(2)/min (schedule B). Forty-six patients were treated with 176 courses at 7 dose levels. The MTD for schedule A was 1,300 mg/m(2) and 200 mg/m(2) and for schedule B was 1,000 mg/m(2) and 200 mg/m(2) for gemcitabine and paclitaxel, respectively. The DLT for schedule A was neutropenia and for schedule B was neutropenia and thrombocytopenia. Nonhematologic toxicity was relatively mild. Gemcitabine and paclitaxel, using both schedules of administration in the current trial, is a promising chemotherapeutic regimen.

Adult↗

Study on cyclospora cayetanensis associated with diarrheal disease in Nepal and Loa PDR.

A study of diarrheal diseases associated with Cyclospora cayetanensis was conducted in Nepal and Lao PDR. A total of 2083 samples were included in this study. Samples in Nepal were collected from October 1999 to August 2002 whereas samples in Lao PDR were collected from February 2002 to June 2003. C. cayetanensis was detected by direct microscopy using ultraviolet and differential interference contrast microscopy. The overall positive rate in Nepal was 9.2% (128/ 1397). A higher positive rate was observed in children aged 10 years and under (11.1%) and was lowest in the age group of 51-60 years (3.1%). A significantly higher positive rate was observed in the summer (rainy season) (12.6%) with the lowest prevalence in the spring (dry season) (1.8%) (p < 0.05). The positive rate was closely associated with rainfall (ml/month). Interestingly, only one of the total 686 samples (0.1%) from Lao PDR was found to be positive for Cyclospora oocysts.

Adolescent↗

[2 cases of loa].

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Child, Preschool↗