Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0038362 (stomatitis)
 8,852 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Piroxantrone, a synthetic intercalating agent, was studied in patients with advanced, measurable gastric adenocarcinoma who had not received prior chemotherapy. The starting piroxantrone dose was 150 mg/m2 given intravenously over 1 hour on day 1 and repeated every 21 days. Response and toxicity could be evaluated in 15 patients. No complete, partial, or minor responses were observed. Toxic effects included granulocytopenia, anemia, vomiting, nausea, anorexia, fatigue, stomatitis, alopecia, hyperbilirubinemia, and increased alkaline phosphatase levels. At the stated dose and schedule, piroxantrone does not possess significant activity against advanced gastric cancer.
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PMID:Phase II trial of piroxantrone in metastatic gastric adenocarcinoma. 789 47

We conducted a multi-institutional (33 institutes), late phase II study with a 21-consecutive-day oral administration of etoposide for malignant lymphoma. Patient entry criteria were either those refractory to standard therapies or those for whom no appropriate therapy was available. A once-daily dose of 50 mg/body was administered for 21 consecutive days. Of the evaluable 83 among 88 entry patients, the overall response rate was 53.0% (44/83), including 10 CR; 52.5% (42/80, 9 CR) with non-Hodgkin's lymphoma and 100% (2/2, 1 CR) with Hodgkin's disease. Regarding abnormal laboratory findings, myelosuppression was observed; the incidence rates of leukopenia (23.3% with Grade 3), neutropenia (32.6%), hemoglobin decrease (17.4%) and thrombocytopenia (4.7%) were 70.9%, 65.1%, 54.7% and 19.8%, respectively. Major adverse reactions and their incidence were: anorexia 43.0%, alopecia 37.2%, nausea/vomiting 32.6%, fatigue 18.6%, stomatitis 15.1%, fever 7.0% and diarrhea 5.8%. Therefore, a 21-consecutive-day oral administration of 50 mg/body/day or 75 mg/body/day appears to be effective for the treatment of malignant lymphoma.
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PMID:[Late phase II study with 21-consecutive-day oral administration of etoposide for malignant lymphoma]. 799 16

We carried out a phase II study on single oral administration of UFT in 17 patients with ovarian carcinoma. Two PR cases were observed out of 13 evaluable cases for a response rate was 15.4%. Side-effects, appearing in 10 of the cases (58.8%) were mainly anorexia (17.6%), stomatitis (17.8%), nausea/vomiting (11.8%), leukopenia (11.8%) and thrombocytopenia (11.8%), but they were not serious. UFT proved useful in the treatment of patients with ovarian carcinoma.
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PMID:[Clinical results of UFT against ovarian carcinoma]. 803 Nov 66

Induction chemotherapy of low-dose CBDCA, 120-hour continuous infusion 5-FU and UFT was applied to 22 patients with untreated head and neck cancer. CBDCA 75 mg/m2 was given on day 1 and, subsequently, 5-FU 1,500 mg/m2/day for 120-hour continuous infusion was started. UFT was administered every day orally at 400-600 mg/day as biochemical modulation. If tumors were reduced and side effects were mild, these schedules were repeated after two weeks. Three patients (14%) achieved a CR and 11 (50%) a PR, for an overall response rate of 64%. Anorexia, nausea, vomiting and stomatitis were the predominant toxicities. They were mild and well tolerable, although severe diarrhea was observed in one case. Good general conditions of patients were kept because of low grade of toxicities. They were important factors for the tolerance of subsequent radiotherapy and surgery. Based on these results, we conclude that the combination of low-dose CBDCA, 5-FU and UFT as biochemical modulation is effective in head and neck cancer.
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PMID:[The effect of induction chemotherapy with CBDCA, 5-FU and UFT in head and neck cancer]. 815 88

A multi-institutional early phase II study of KW-2307 (vinorelbine), a new vinca alkaloid derivative, in advanced or recurrent breast cancer was conducted in 15 nationwide hospitals. KW-2307 was intravenously administered once weekly at doses of 15 to 25 mg/m2. Sixty-five among the enrolled 69 patients were eligible. Response rates were 11.8% (2/17) with 15 mg/m2, 28.0% (7/25) with 20 mg/m2 and 17.4% (4/23) with 25 mg/m2, and the overall response rate was 20.0%. Once-weekly intravenous administration of 20 mg/m2 was estimated to be the optimal dose of KW-2307 from the results. The major side effect was leucopenia, which was the dose-limiting factor in this study. Other subjective or objective side effects included anorexia, nausea-vomiting, phlebitis, fever, general fatigue and stomatitis, but none of them was serious.
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PMID:[Early phase II study of KW-2307 in advanced or recurrent breast cancer. KW-2307 Cooperative Study Group (Breast Cancer Section]. 818 37

A multi-institutional late phase II study of KW-2307 (vinorelbine), a new vinca alkaloid derivative, in advanced or recurrent breast cancer was conducted in 26 nationwide hospitals. KW-2307 was intravenously administered at a dose of 20 mg/m2 once weekly. Eighty among the enrolled 82 patients were eligible. The overall response rate was 30.0% (24/80) with 4 CR, 20 PR, 5 MR, 22 NC, 17 PD and 12 unevaluable patients. The major side effect was leucopenia, which was the dose-limiting factor in this study. Other subjective or objective side effects included general fatigue, nausea-vomiting, anorexia, paresthesia, fever and stomatitis, but none of them was serious.
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PMID:[Late phase II study of KW-2307 in advanced or recurrent breast cancer. KW-2307 Cooperative Study Group (Breast Cancer Section)]. 818 38

A late phase II study of idarubicin hydrochloride combined with vincristine and prednisolone was conducted in adult patients with acute lymphocytic leukemia (ALL) in the first relapse as a multi-center joint research project. The dosages used were idarubicin 12 mg/m2/day i.v. for 3 consecutive days (day 1-3), vincristine 1.4 mg/m2 i.v. (day 1) and prednisolone 60 mg/m2/day po for 5 consecutive days (day 1-5). The number of evaluable patients was 20. The patients showed responses including 3 complete remissions (CR) and 10 partial remissions (PR), with an efficacy rate (CR + PR) of 65.0%. Adverse reactions occurred in 19 of 20 patients. The main symptoms were gastrointestinal symptoms including anorexia, nausea/vomiting, and stomatitis and fever, infection, and alopecia. Abnormal laboratory data were observed in 6 of 20 patients with 13 events. Although one case of an increase in GPT with WHO grade 3 was observed, the other cases were not of significance. From the above study, idarubicin hydrochloride was considered to be effective in relapsed ALL patients in combination therapy with vincristine and prednisolone.
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PMID:[A late phase II study of idarubicin hydrochloride in adult patients with acute lymphocytic leukemia. Idarubicin Study Group]. 821 75

Leucovorin, given usually by i.v. injection or orally changes to 5, 10-methylene tetrahydrofolate in tumor as well as normal cells. And in normal FdUMP, an active metabolite of 5-FU, binds tightly to thymidylate synthase in the presence of cofactor, 5, 10-methylene tetrahydrofolate. This interaction leads to potentiate the cytotoxic effect of 5-FU by prolonged inhibition of thymidylate synthase. Phase I study using l-leucovorin (l-LV), an active form of leucovorin, combined with 5-FU, was conducted. In the weekly schedule, 5-FU was fixed to 600mg/m2, and l-LV dose was escalated from 125 mg/m2 to 250mg/m2, if toxicity was acceptable. On the other hand, in the five consecutive-day schedule, 5-FU was fixed to 370mg/m2 and l-LV was escalated from 25mg/m2 to 50mg/m2, 100mg/m2 and 200 mg/m2. l-LV 10mg/m2 was tested as reference. On weekly schedule of l-LV 250mg/m2, grade III diarrhea was seen in 2 cases and grade IV leucopenia was seen in one. In five consecutive-day schedule, at each dose of l-LV, stomatitis, nausea plus vomiting, anorexia, anemia and leucopenia were seen. However, the increase of toxicities were not seen by dose escalation of l-LV. Then, we have been conducted a randomized early phase II study using 250 mg/m2 of l-LV weekly (arm A) and 100mg/m2 (arm B) or 10mg/m2 (arm C) of l-LV for 5 consecutive days in gastric and colorectal cancer by multicenter cooperative study. Plasma concentrations of l-LV were maintained > 10(-5) mol/L for over 5 hrs. after 2 hrs. infusion of 250 mg/m2 of l-LV and for over one hr. after a rapid injection of 100mg/m2 of l-LV.
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PMID:[Phase I study of 5-fluorouracil and l-leucovorin]. 845 86

We examined the toxicity of both single and multiple subcutaneous injections of recombinant human ciliary neurotrophic factor (rhCNTF) in 72 patients with ALS, in doses ranging from 2 to 100 micrograms/kg. Adverse events were generally dose related and ranged from mild to severe. The tolerability of daily subcutaneous rhCNTF was equivalent to placebo at doses < or = 5 micrograms/kg/day. At higher doses, anorexia, weight loss, reactivation of herpes simplex virus (HSV1) labialis/stomatitis, cough, and increased oral secretions occurred.
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PMID:Toxicity and tolerability of recombinant human ciliary neurotrophic factor in patients with amyotrophic lateral sclerosis. 890 53

This phase I trial of idarubicin (IDA) was conducted in 32 patients with acute leukemia and chronic myelogenous leukemia (CML) in blastic crisis (CML/BC) who either had failed to achieve a complete remission (CR) after initial induction therapy or had relapsed after CR. IDA was administered at dosages ranging from an initial dose of 5 mg/m2/d for 3 days with an increment of 2.5 mg/m2/d to 15 mg/m2/d for 3 days. The dose-limiting toxicities (DLTs) were thought to be stomatitis and anorexia. The maximum tolerated dose (MTD) was determined to be 15 mg/m2/d for 3 days (45 mg/m2 per course). Bone marrow toxicity was significant when greater than 10 mg/m2/d of IDA was given. When IDA was administered at this dosage or higher, there were three CRs and four partial responses, with an overall response rate of 26.9% in 26 assessable patients. It is recommended that a phase II study be undertaken at an IDA dosage of 10 to 15 mg/m2/d for 3 consecutive days in the treatment of acute leukemia. Twenty-one of 32 patients were also studied for the pharmacokinetics of IDA. The terminal half-life (t1/2) values for IDA were 6.4 to 15.1 hours in plasma and 8.09 to 16.34 hours in blood cells. The t1/2 values for idarubicinol were much longer: 43.46 to 51.01 hours in plasma and 36.61 to 54.70 hours in blood cells. Concentrations of idarubicinol in plasma and blood cells exceeded those of IDA 2 to 4 hours after the start of treatment and remained elevated for a long time. The area under the curve (AUC) of idarubicinol in plasma was 5.16 to 8.36 times higher than that of IDA, and the AUC of idarubicinol in blood cells was 2.05 to 4.57 times higher than that of IDA. The AUCs of both IDA and idarubicinol increased dose-dependently over the dosage range of 5 to 15 mg/m2/d. When two-compartment multiple-dose models were used, plasma t1/2 alpha and t1/2 beta values of IDA were 0.25 +/- 0.13 and 9.4 +/- 3.4 hours, respectively. The steady-state volume of distribution (Vdss) was 934.9 +/- 370.7 L/m2, and the plasma clearance was 82.3 +/- 29.7 L/h/m2. The urinary excretion of IDA and its metabolite was low. The mean cumulative urinary recovery rates were 2.04% for IDA and 11.53% for idarubicinol up to 7 days.
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PMID:A phase I study of idarubicin hydrochloride in patients with acute leukemia. The Idarubicin Study Group of Japan. 891 10


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