Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0027497 (nausea)
 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Thirty-four patients with metastatic gastric adenocarcinoma were treated with the combination of chemotherapy and radiation therapy in a Phase II trial. Induction chemotherapy consisted of one cycle of 5-fluorouracil (5-FU), adriamycin, and BCNU (FAB), followed in 4 weeks by a cycle of 5-FU, adriamycin and mitomycin-C (FAM). In responding and stable patients, consolidation radiotherapy to major sites of disease, followed by maintenance FAM, was administered. Twelve of 30 (40%) patients with measurable disease responded (3 complete responses and 9 partial responses), with a median response duration of 6.0 months. Toxicity was moderate and consisted of nausea, vomiting, and myelosuppression. No additive effects for this combined modality approach could be demonstrated.
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PMID:Phase II trial of sequential chemotherapy and low-dose radiotherapy in advanced gastric adenocarcinoma. A Southwest Oncology Group Pilot Study. 366 88

Thirty evaluable patients with histologically confirmed primary liver cancer (PLC) were treated with neocarzinostatin (NCS). All patients had measurable disease and an Eastern Cooperative Oncology Group (ECOG) performance status of 1, 2, or 3. NCS 2250 units/m2 was given daily for 5 days, repeated at 28-day intervals. Hemopoietic suppression was the major side effect. In 23 of 30 patients (13 with leukopenia and 19 with thrombocytopenia), this toxic effect was documented. Other toxic effects included nausea, vomiting, allergic-type reaction, and elevation of NPN. Partial response, with a median duration of 12.7 weeks (range 4--37 weeks) was observed in seven patients. In nine patients the response was classified as no change, and in 14 patients there was progressive disease. NCS has some therapeutic activity in patients with PLC.
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PMID:A phase II study of neocarzinostatin (NSC 157365) in malignant hepatoma. An Eastern Cooperative Oncology Group pilot study. 624 4

From 1978 to 1981, 537 patients with advanced non-small cell lung cancer were randomly assigned to three regimens containing cyclophosphamide and doxorubicin alone or in combination with methotrexate or cisplatin. Eligible patients had measurable disease and had no prior exposure to chemotherapy. Of the patients entered on the study, 505 were evaluable for toxicity and 488 were evaluable for response. The overall response rate (complete and partial responses) was only 9%. Response rates did not vary significantly with respect to treatment regimen, histologic subtypes, extent of disease, or performance status. There was no survival advantage for any regimen. The major toxicities were myelosuppression and nausea-vomiting. These doxorubicin-based chemotherapy regimens produced disappointing results in patients with advanced non-small cell lung cancer. A search for more active antitumor agents in lung cancer is necessary.
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PMID:Randomized phase III comparison of three doxorubicin-based chemotherapy regimens in advanced non-small cell lung cancer: a Southeastern Cancer Study Group trial. 637 50

A phase I clinical study of tegafur (ftorafur) was conducted in 29 patients with various advanced solid tumors. To evaluate its efficacy and toxicity, the initial dose of 0.5 g/m2/day x 21 days at 3-week intervals was progressively increased to a maximum dose of 1.5 g/m2/day. Tegafur was administered orally in two or three divided doses. Diarrhea was the dose-limiting toxic effect and occurred more often in patients with abnormal pretreatment liver function. Nausea occurred in about one-half of the patients, but vomiting was infrequent. Skin rash and mucositis occurred in 10% and 7% of the patients, respectively. Neurologic toxic effects of tegafur were infrequent and mild. The hematologic toxicity of tegafur was minimal. Antitumor activity could be evaluated in 21 patients with measurable disease. One complete and three partial responses were observed in four of 17 patients who had adenocarcinoma of unknown primary origin. All responses occurred at doses greater tan or equal to 1.0 g/m2/day. The recommended dose of tegafur for this schedule of administration is 1.0 g/m2/day.
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PMID:Phase I evaluation of oral tegafur. 641 58

Both DFMO and methyl-GAG inhibit sequential enzymatic reactions in the pathway of polyamine biosynthesis. Since polyamines may be important factors in proliferation of cancer cells, we initiated a phase-I study of these agents in patients with advanced cancer. DFMO was given by mouth at a constant daily dose of 4 g/m2 starting on day 1 of the treatment protocol. The dose of methyl-GAG ranged from 200 to 700 mg/m2 administered IV every 2 weeks beginning on day 4. Twenty-two patients were entered into the protocol. Toxic reactions to this therapy were dose-related and included nausea, fatigue, diarrhea, and myelosuppression. One patient with colon cancer experienced a greater than 50% decrease in measurable disease but developed severe myelotoxicity. While DFMO was well tolerated, the combination of drugs appeared to cause substantially more hematologic and gastrointestinal toxicity than encountered during our recent experience with methyl-GAG used alone. We suggest that future studies of this drug combination carefully evaluate levels of polyamines and inhibition of enzymatic activity to minimize toxicity.
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PMID:Sequential inhibition of polyamine synthesis. A phase I trial of DFMO (alpha-difluoromethylornithine) and methyl-GAG [methylglyoxal-bis(guanylhydrazone)]. 641 31

Thirty six patients with advanced solid tumors (24 lung: 3 oat-cell, 14 squamous, 7 adenocarcinomas, 3 soft tissue sarcomas, 6 breast carcinomas; 1 seminoma; 2 ovarian adenocarcinomas) entered a phase II study of high-dose ifosfamide (IF) administered in combination with the uroprotective agent sodium 2-mercapto-ethane-sulfonate (Mesna). Fourteen patients had prior treatment; most patients with lung cancer (22/24) were previously untreated; all had measurable disease. The patients median age was 59 (range 31-74). IF was given at 1.8 g/m2 days 1-5 q 4 weeks. Mesna was given after each IF injection at 0, 4 and 8 h randomly, either i.v. (0.36 g/m2) or orally (0.72 g/m2). Twenty-four patients had greater than or equal to 3 courses of therapy, 9 had 2 courses, and 3 had only 1 course; 129 courses were evaluated for toxicity. Mesna was given orally (17 patients, 57 courses) or i.v. (19 patients, 72 courses). The following side-effect were observed: no gross hematuria, microhematuria (14 courses), transitory mild proteinuria (34 courses), leukopenia grade I-II ECOG (26 courses), anemia grade I ECOG (31 courses), 1 case of pancytopenia, alopecia (31 patients), nausea (moderate, 33 courses; severe, 6 courses), vomiting (moderate, 17 courses; severe, 1 course). Five patients showed a partial response (1 oat-cell carcinoma, 2 with squamous lung cancer, 1 with ovarian carcinoma, 1 with breast carcinoma), 14 showed a minor response (2 patients with oat-cell carcinoma, 2 with lung adenocarcinoma, 5 with squamous lung cancer, 1 with seminoma, 1 with sarcoma, 1 with ovarian carcinoma), and 14 showed progression of disease (7 patients with squamous cell lung cancer, 4 with lung adenocarcinoma, 1 with sarcoma, 2 with breast carcinoma). Considering partial plus minor responses, ifosfamide produced some degree of tumor reduction (PR + MR) in 12/23 (52.1%) lung cancer patients. The data reported support the conclusions that Mesna can prevent high-dose IF bladder toxicity, that IF is active in advanced solid tumors, including lung cancer, and that the IF + Mesna combination is a generally safe treatment procedure.
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PMID:Phase II study of ifosfamide combined with Mesna uroprotection in advanced non-small-cell lung carcinoma and other solid tumors. 643 51

A phase II study of methanesulfonamide, N-(4-(9 acridinylamino)-3-methoxyphenyl)-(m-AMSA) was undertaken by the Eastern Cooperative Oncology Group. Thirty-five evaluable patients were studied, 18 of whom had had no prior therapy and eight of whom had been treated only one cytotoxic drug. Thirty-one of these patients were ECOG performance status 2 or better. The dose of m-AMSA employed in this study was 40 mg/M2 as an I.V. infusion over 20 minutes daily for 3 days, repeated every 3 weeks. Leukopenia was found to be dose-limiting; thrombocytopenia and anemia were also observed. Other prominent toxicities included anorexia, nausea, and vomiting. No cardiovascular toxicity was observed in this study, but none of the patients had received prior anthracycline therapy. Only one partial response of measurable disease was observed, all other patients had progressive disease on m-AMSA therapy. No significant clinical activity of m-AMSA against malignant melanoma was demonstrated in this very favorable group of patients.
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PMID:Phase II study of m-AMSA in advances malignant melanoma. 689 95

1-beta-D-Arabinofuranosylcytosine (ara-C), 2 or 3 g/sq m, was administered as a 1-hr i.v. infusion every 12 hr for 10 or 12 doses to patients with acute leukemia and refractory lymphoma. Four of seven patients with relapsed or refractory acute myelocytic leukemia and two of four patients with previously untreated acute myelocytic leukemia achieved complete remission. Of five treatment failures, two patients had leukemia which was clearly resistant to high-dose ara-C, and three patients died of infections or hemorrhagic complications during periods of pancytopenia. Three patients with acute myelocytic leukemia in remission received high-dose ara-C as consolidation therapy following previous courses of intensive, multiagent consolidation chemotherapy. Two of these three patients had prolonged thrombocytopenia following high-dose ara-C. Five patients with refractory acute lymphocytic leukemia were treated. Three patients achieved partial remission, and two patients had drug-resistant disease. Complete or partial disappearance of measurable disease parameters was seen in three of three patients with refractory lymphoma. Response was seen in five of five patients with meningeal leukemia, including complete response in one patient with extensive meningeal infiltration. Toxicity of this regimen was generally moderate and limited to pancytopenia and mild nausea. Patients who had received prior multiagent consolidation chemotherapy appeared to be at greater risk for hematopoietic toxicity. Patients who had received prior cranial irradiation or intrathecal chemotherapy appeared to be at greater risk for neurological toxicity. Plasma levels of ara-C immediately after completion of the infusion were 17.96 +/- 8.02 (S.D.) and 35.0 +/- 2.8 micrograms/ml for doses of 2 and 3 g/sq m, respectively. From 160 to 720 min following completion of the infusion, the plasma levels of drug were comparable to steady-state levels achieved with a continuous infusion of ara-C at 100 mg/sq m over 24 hr. A high degree of penetration into the central nervous system was demonstrated. High-dose ara-C has substantial activity against leukemic and lymphomatous cell populations, including cell populations resistant to conventional doses of the drug, and is an effective treatment modality for patients with these diseases. The high degree of penetration into the central nervous system suggests that this drug regimen may be useful as consolidation therapy for patients at high risk for central nervous system disease.
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PMID:A pilot study of high-dose 1-beta-D-arabinofuranosylcytosine for acute leukemia and refractory lymphoma: clinical response and pharmacology. 694 42

Aclacinomycin A (ACM-A), an anthracycline analog, was given to 17 patients with solid tumors and to one patient with multiple myeloma, in a phase I clinical trial. A single dose of 60-120 mg/m2 was given every 3 weeks. Dose-limiting toxicity was myelosuppression, especially thrombocytopenia. Granulocytopenia was variable and did not always recover by Day 21 in time for the next ACM-A treatment. Other toxic effects were nausea, vomiting, urticaria, and elevation of hepatic enzymes. Alopecia was not a side effect, even in patients receiving multiple courses of ACM-A. Nine patients were monitored with 24-hour continuous ECG recordings (Holter) on 19 ACM-A treatment days. The incidence of premature atrial and ventricular beats was significantly increased following ACM-A administration. In addition, one patient developed episodes of high-degree atrioventricular block and complete heart block after each of four ACM-A doses, necessitating the insertion of a pacemaker. No antitumor responses were seen in the ten patients who had measurable disease and who had received two or more courses of ACM-A. The recommended doses for solid tumor phase II studies are 100 mg/m2 as a single dose every 4 weeks for patients with high performance status and minimal prior chemotherapy and 60 mg/m2 every 4 weeks for all other patients. Until the acute cardiac effects of ACM-A are further understood, we recommend that all patients receiving ACM-A be monitored by ECG recordings.
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PMID:Phase I trial of aclacinomycin A. 695 61

Methyl-GAG, a polyamine synthesis inhibitor, was prospectively evaluated in the treatment of advanced renal adenocarcinoma. Twenty-five patients with measurable disease received methyl-GAG weekly at a starting dose of 500 mg/m2 iv, with dose escalation by 50 mg/m2/week (maximum dose, 825). All 25 patients are evaluable for response. Four of these patients (16%) achieved responses including three partial responses and one complete response, with a median duration of 9 weeks (range, 4--15). Nine patients (36%) remained stable and 12 (48%) had progressive disease. In the four responders, regression of disease occurred within the first 4 weeks of therapy. Toxic effects were generally mild and included nausea or vomiting (68%), myalgia (44%), mucositis (40%), neuralgia (40%), weight loss (32%), diarrhea (24%), skin rash (8%), leukopenia (8%), and genital ulcers (4%). We conclude that methyl-GAG has clear, albeit limited, activity against renal adenocarcinoma.
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PMID:Phase I--II trial of methyl-GAG in the treatment of patients with metastatic renal adenocarcinoma. 722 67


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