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  • 1
    Electronic Resource
    Electronic Resource
    Vindesine: Phase II evaluation in colon cancer and description of its platelet stimulating activity (1982)
    Springer
    Cancer chemotherapy and pharmacology 9 (1982), S. 41-44 
    Details
    ISSN: 1432-0843
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Fifteen previously treated patients with measurable metastatic colon carcinoma were entered into a phase II study of vindesine, 3 mg/m2/week IV. Fourteen patients were evaluable for response. No objective tumor response was observed; however, seven patients experienced stable disease lasting 9, 10, 13, 15, 16, 19, and 26 weeks. Neurologic toxicity was the most common nonhematologic side-effect noted, manifesting as abdominal pain, constipation, paralytic ileus, or paresthesias. Leukopenia was observed in 16% of the 104 weekly courses. Nine patients had a 50% increase of their platelet counts above their pretreatment platelet counts; six patients had a doubling of their pretreatment platelet counts. Mean platelet counts revealed a linear increase with successive treatments during the initial 8 weeks of therapy. Serial CEA determinations demonstrated a parallel relationship with clinical progression in six of seven patients.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00296760
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  • 2
    Electronic Resource
    Electronic Resource
    Oral uracil and Ftorafur plus leucovorin: pharmacokinetics and toxicity in patients with metastatic cancer (2000)
    Springer
    Cancer chemotherapy and pharmacology 46 (2000), S. 351-356 
    Details
    ISSN: 1432-0843
    Keywords: Key words Ftorafur (tegafur) ; 5-FU ; UFT ; Pharmacology ; Toxicity
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose: To assess the pharmacokinetics of Ftorafur (tegafur, FT), 5-fluorouracil (5-FU), and uracil in 31 cancer patients who were enrolled in phase I studies of oral uracil and FT (UFT). The correlation between pharmacokinetic parameters and toxic effects of UFT was evaluated. Methods: Uracil and FT were orally administered in a 4:1 molar ratio at FT doses of 200–400 mg/m2 per day. Patients also received leucovorin at 150 mg/day. Daily doses were divided into three doses and administered at 8-h intervals for 28 consecutive days. Plasma FT concentrations were measured by high-performance liquid chromatography, and plasma 5-FU and uracil concentrations were determined using gas chromatography-mass spectrometry. National Institutes of Health Common Toxicity Criteria were used for assessment of toxicity. Results: The concentrations of FT, 5-FU, and uracil showed wide interpatient variations. Maximum plasma concentrations (Cpmax) of all three compounds were achieved in 0.3 to 4.0 h. At the various study doses, the terminal half-life (t1/2β) of FT ranged from 3.9 to 5.9 h, the area under the concentration-versus-time curve (AUC0–6h) ranged from 16,220 to 52,446 (ng/ml)h, the total clearance (ClT) ranged from 100 to 175 ml/min, and the steady-state volume of distribution (Vdss) ranged from 18.3 to 28.7 l. The 5-FU generated from FT had an apparent distribution half-life (t1/2α) and an apparent elimination half-life (t1/2β) of 0.3–1.3 h and 4.9–7.0 h, respectively. The AUC0–6h of 5-FU ranged from 120 to 325 (ng/ml)h. Uracil had a t1/2α of 0.2–0.5 h and the level quickly returned to the endogenous level. The AUC0–6h for uracil ranged from 605 to 3764 (ng/ml)h, the ClT ranged from 3225 to 7748 ml/min, and the Vdss ranged from 341 to 1354 l. The Cpmax and AUC0–6h of both FT and uracil were significantly correlated with FT doses (P-values of 0.0244 and 0.0112) and with uracil doses (P-values of 0.0346 and 0.0083), respectively. In addition to interpatient variations, intrapatient variations were also observed in six patients who had pharmacology studies done on days 1 and 26 ± 2 at the same study dose. We found that the repeated treatment with UFT caused cumulative increases in the values of Cpmax, Ctrough, and AUC0–6h of FT and 5-FU. The major toxic effects observed were diarrhea and nausea and vomiting. The occurrence of these toxic effects correlated significantly with the Cpmax and AUC0–6h of 5-FU. Conclusions: The pharmacology studies showed that FT and uracil were readily absorbed orally and that FT was rapidly converted to 5-FU. The preliminary findings suggest that determination of plasma levels of 5-FU after oral administration of UFT may help predict subsequent toxic effects.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002800000156
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  • 3
    Electronic Resource
    Electronic Resource
    Phase II trial of piroxantrone in metastatic gastric adenocarcinoma (1994)
    Springer
    Investigational new drugs 12 (1994), S. 263-265 
    Details
    ISSN: 1573-0646
    Keywords: gastric carcinoma ; piroxantrone ; stomach carcinoma
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary 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.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00873970
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  • 4
    Electronic Resource
    Electronic Resource
    Phase II trial of ZD1694 (TomudexTM) in patients with advanced pancreatic cancer (1995)
    Springer
    Investigational new drugs 13 (1995), S. 355-358 
    Details
    ISSN: 1573-0646
    Keywords: TomudexTM ; thymidylate synthase inhibitor ; pancreatic carcinoma
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Background Currently available therapies for advanced pancreatic cancer offer only palliative benefits, and patients with this disease have a poor prognosis. We undertook a phase II trial of ZD1694 (TomudexTM), a quinazoline folate analogue that is a potent and selective thymidylate synthase inhibitor, to determine this analogue's efficacy and safety in patients with advanced pancreatic adenocarcinoma. Patients and methods ZD1694, 3.0 mg/m2, was administered to 42 adult patients with pancreatic adenocarcinoma as a 15-minute intravenous infusion every 3 weeks for up to 6 doses. Objective tumor response was assessed every 6 weeks; clinical examinations, adverse event assessments, and clinical laboratory tests were performed every 3 weeks. Results ZD1694 produced an overall response rate of 5% (95% confidence limits [CI], 1% to 16%) in the study group. Of 42 patients, 2 (5%) had a partial response, 12 (29%) had stable disease, 21 (50%) had disease progression, and 5 (11%) could not be evaluated for response. Grade 3 vomiting, grades 3 and 4 fever, grade 3 leukopenia, grade 4 thrombocytopenia, and grades 3 and 4 liver function elevations were reported. Toxic effects with ZD1694 were reversible and manageable. Conclusions ZD1694 has an acceptable safety profile but limited activity in patients with advanced pancreatic cancer.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00873144
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  • 5
    Electronic Resource
    Electronic Resource
    Phase I trial of Uracil-Tegafur (UFT) plus oral leucovorin: 14-day schedule (1997)
    Springer
    Investigational new drugs 15 (1997), S. 123-128 
    Details
    ISSN: 1573-0646
    Keywords: tegafur ; ftorafur ; uracil ; 5-fluorouracil ; colon carcinoma ; rectal carcinoma
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract We previously reported results of a Phase II trial of UFT [Taiho Pharmaceutical Ltd., Tokyo, Japan; (BMS-200604) Bristol-Myers Squibb, Princeton, NJ], an oral 4:1 molar concentration of uracil and tegafur, plus oral leucovorin for metastatic colorectal carcinoma (Pazdur et al, J. Clin. Oncol. 12:2296-2300, 1994]. Our results demonstrated that a 28-day schedule of this combination produced a response rate similar to that obtained with conventional intravenous fluorouracil (5-FU)-plus-leucovorin regimens but without the severe or life-threatening neutropenia or oral mucositis that complicates intravenous 5-FU regimens. The current Phase I trial examines the dose-limiting toxic effects and maximum tolerated dose of a 14-consecutive-day schedule of UFT plus oral leucovorin in 14 patients who had histologically proven cancer and had received prior chemotherapy. The daily UFT plus leucovorin dose was divided into three doses administered orally every 8 hours. In this study, the UFT dose was escalated while the leucovorin dose remained at 150 mg/day. Of the 14 patients, 4 were initially treated at the 350-mg/m2/day UFT level for 14 days without any dose-limiting toxic reactions. Subsequently, another 7 patients were treated at the 400-mg/m2/day level; grade 3 diarrhea developed in 3 of these 7 (with severe abdominal cramping in 2 cases and severe nausea and vomiting unresponsive to antiemetics in the third). To better define the starting dose for phase II studies, an additional 3 patients were treated at the 350-mg/m2/day dose level. Of the total 7 patients treated at 350 mg/m2/day, grade 3 toxic events (diarrhea) developed in 2 patients. Grade 1-2 toxic effects noted at this level included fatigue, stomatitis, skin rash, abdominal pain, nausea, and vomiting. Neither partial nor complete responses were observed in this trial. The maximum tolerated dose of this schedule is 350 mg/m2/day UFT plus 150 mg/day oral leucovorin. However, because of this schedule's inferior dose intensity compared with that of the 28-day schedule of UFT plus leucovorin, subsequent development of UFT in the United States has focused on the 28-day regimen.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1005808822565
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  • 6
    Electronic Resource
    Electronic Resource
    Phase II trial of 9-aminocamptothecin (NSC 603071) administered as a 120-hour continuous infusion weekly for three weeks in metastatic colorectal carcinoma (1998)
    Springer
    Investigational new drugs 16 (1998), S. 341-346 
    Details
    ISSN: 1573-0646
    Keywords: 9-AC ; 9-aminocamptothecin ; camptothecin ; colorectal cancer ; phase II
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract 9-Aminocamptothecin (9-AC) is a camptothecin derivative with broad antitumor activity in preclinical studies. Prior investigations suggested that prolonged maintenance of 9-AC lactone plasma concentrations above 10 nmol/l and frequent administration of the drug are important determinants of antitumor activity. Our phase II study, therefore, examined a 5-day continuous infusion of 9-AC weekly for 3 weeks in patients with advanced colorectal cancer. Eighteen patients previously untreated for metastatic disease received 480 μg/m2/day of 9-AC. No responses were observed in 17 evaluable patients. Severe toxicities included granulocytopenia, nausea, vomiting and diarrhea. The median absolute granulocyte count (AGC) nadir was 2,300/μl (range 0–9,000/μl) and occurred on day 10. Eight patients received an escalated dose of 600 μg/m2/day. The median AGC nadir at the escalated dose was 1,500/μl (range: 300–2,700/μl) and occurred on day 22. The median number of courses given was 2 (range: 1–8); and the median time to disease progression was 8 weeks (range: 1–40 weeks). 9-AC administered by this schedule lacked antitumor activity in patients with advanced colorectal carcinomas.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1006248700232
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  • 7
    Electronic Resource
    Electronic Resource
    Introduction (2000)
    Springer
    Investigational new drugs 18 (2000), S. 297-298 
    Details
    ISSN: 1573-0646
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1006442324310
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  • 8
    Electronic Resource
    Electronic Resource
    Phase II study of intravenous 6-thioguanine in patients with advanced carcinoma of the pancreas (1991)
    Springer
    Investigational new drugs 9 (1991), S. 369-371 
    Details
    ISSN: 1573-0646
    Keywords: intravenous 6-thioguanine ; pancreatic carcinoma
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary In a phase II study, 32 patients with advanced pancreatic carcinoma were treated with intravenous 6-thioguanine. A 30-min infusion of 55 mg/m2 (starting dose) was administered once a day for 5 consecutive days, the course being repeated every 5 weeks. A median of two courses (range, 1–10) was administered. Among the 32 patients, 30 having measurable cancer and optimum follow-up were fully assessable for response. One patient achieved a partial response of extensive liver metastases (12 + months), and another patient had a transient minor response (5 weeks). Cancer in 27 of 30 assessable patients progressed during intravenous 6-thioguanine treatment. Myelosuppression, although frequent, was mild to moderate at these doses and did not result in significant morbidity. Nonhematologic toxicities were also mild. Our data suggest that intravenous 6-thioguanine given at this schedule is ineffective in previously untreated patients with advanced carcinoma of the pancreas.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00183584
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  • 9
    Electronic Resource
    Electronic Resource
    Phase II trial of fazarabine in advanced colorectal carcinoma (1992)
    Springer
    Investigational new drugs 10 (1992), S. 39-42 
    Details
    ISSN: 1573-0646
    Keywords: colorectal carcinoma ; fazarabine ; phase II trial
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract A total of 15 patients with measurable advanced colorectal adenocarcinoma were prospectively treated with fazarabine (Ara-AC), reconstituted in dimethyl sulfoxide, and administered at a starting dose of 48 mg/m2/day as a continuous intravenous infusion for three days. The dose was repeated every 21 days and dose escalations or reductions were made on the basis of toxicities encountered in the preceding course. No patient achieved either a complete or partial response. Major toxicities encountered were granulocytopenia, thrombocytopenia, nausea, vomiting, anemia, and headache. All toxicities were reversible upon discontinuation of the drug and no life-threatening toxicities occurred. These data indicate that further clinical trials in colorectal carcinoma with this agent and schedule of administration are not warranted.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01275479
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  • 10
    Electronic Resource
    Electronic Resource
    Phase II trial of intravenous melphalan in advanced colorectal carcinoma (1994)
    Springer
    Investigational new drugs 12 (1994), S. 133-136 
    Details
    ISSN: 1573-0646
    Keywords: colorectal carcinoma ; chemotherapy ; alkylating agent
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Background Relatively few studies have examined the activity of alkylating agents in the treatment of advanced colorectal adenocarcinoma. Recent reports have suggested possible therapeutic activity for high-dose intravenous melphalan administered with autologous bone marrow transplantation (BMT) support. We conducted a phase II study to determine the efficacy of administering intravenous melphalan at doses that do not require BMT support in patients with advanced colorectal adenocarcinoma. Patients and methods Fifteen patients with histologically proven, bidimensionally measurable disease were treated. The starting dose of melphalan was 30 mg/m2, with dose escalation permitted. Results No objective responses were observed. Toxic effects were primarily reversible granulocytopenia and thrombocytopenia. There were no treatmentassociated deaths. Conclusion Melphalan's lack of efficacy at the doses administered does not disprove the steep chemotherapy dose-response relationship postulated for many solid tumors. However, we feel that it is unlikely that repetitive courses of high dose melphalan with autologous BMT support will be a practical approach to the management of advanced colorectal adenocarcinoma.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00874443
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