ALBERT — All Library Books, journals and Electronic Records Telegrafenberg

1

Electronic Resource

Phase II trial of N-methylformamide in patients with metastatic melanoma (1991)

Eton, Omar ; Bajorin, Dean F. ; Casper, Ephraim S. ; [et al.]

Springer

Investigational new drugs 9 (1991), S. 97-100

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ISSN: 1573-0646

Keywords: n-methylformamide ; melanoma ; chemotherapy ; phase II

Source: Springer Online Journal Archives 1860-2000

Topics: Chemistry and Pharmacology , Medicine

Notes: Summary Sixteen patients with metastatic melanoma were treated with N-methylformamide (NMF), a polar-planar compound with in vitro cytotoxic and differentiating properties. Sixteen patients were evaluable for toxicity and 14 for response. The initial four patients received an intravenous bolus of NMF 800 mg/m2 daily for 5 consecutive days every 28 days. Because of excessive gastrointestinal toxicity, the dose was reduced to 700 mg/m2/day for the subsequent 12 patients. Two patients had immediate adverse effects from NMF; one had a grand mal seizure and the other developed severe abdominal pain. Nausea, vomiting and abdominal pain were dose-limiting. Transient elevation of liver function tests occurred in all patients. Myelosuppression was not observed. There were no objective responses among 14 evaluable patients (95% confidence limits 0–20%). One patient with pulmonary metastases had a minor response lasting 13 months. Median time to progression of disease was one month. NMF in these doses and schedule lacks clinical efficacy in the treatment of metastatic melanoma.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1007/BF00194557

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2

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Phase II trial of fazarabine (arabinofuranosyl-5-azacytidine) in patients with advanced pancreatic adenocarcinoma (1992)

Casper, Ephraim S. ; Schwartz, Gary K. ; Kelsen, David P.

Springer

Investigational new drugs 10 (1992), S. 205-209

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ISSN: 1573-0646

Keywords: phase II ; fazarabine ; adenocarcinoma ; pancreas

Source: Springer Online Journal Archives 1860-2000

Topics: Chemistry and Pharmacology , Medicine

Notes: Abstract We conducted a phase II evaluation of fazarabine 1.75–2.0 mg/m2hr over 72 hours every 28 days in 14 previously untreated patients with advanced adenocarcinoma of the pancreas. The intial dose was 1.75 mg/m2/hr in 10 patients, and 2.0 mg/m2hr in 4 patients. The dose was escalated in 8 patients, including all 4 who started at the higher dose level. Toxicity was unexpectedly mild. The median WBC nadir was 4.4 (range: 2.4–15.8)×103/μl, the median absolute neutrophil nadir was 3.2 (range: 0.9–13.0)×103/μl, and the median platelet count was 134.0 (range: 48.0–291.0)×103/μl. Gastrointestinal toxicity was generally mild. No major responses were seen, excluding, with 95% confidence, a response rate in excess of 20%.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1007/BF00877247

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3

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Phase II trial of gemcitabine (2,2′-difiuorodeoxycytidine) in patients with adenocarcinoma of the pancreas (1994)

Casper, Ephraim S. ; Green, Mark R. ; Kelsen, David P. ; [et al.]

Springer

Investigational new drugs 12 (1994), S. 29-34

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ISSN: 1573-0646

Keywords: pancreas ; adenocarcinoma ; gemcitabine ; 2,2′-difluorodeoxycytidme ; phase II

Source: Springer Online Journal Archives 1860-2000

Topics: Chemistry and Pharmacology , Medicine

Notes: Abstract Gemcitabine is a novel nucleoside analog which demonstrated a broad spectrum of preclinical acitivity in solid tumor models, and responses in patients with pancreas cancer during phase I evaluation. Patients with measurable adenocarcinoma of the pancreas who had received no previous chemotherapy were eligible for this multicenter phase II clinical trial. Gemcitabine 800 mg/m2 was administered intravenously weekly for 3 consecutive weeks, followed by one week rest, every 4 weeks. Forty-four patients entered the trial; 35 had at least 2 cycles of therapy. Partial response was observed in 5 patients (11%, estimated 95% confidence interval 2–20%), with a median duration of 13 months. All responding patients had stabilization or improvement in performance status. Fourteen patients had stable disease of 4 or more months. The median WBC nadir was 3.8 × 103/μl (range 1.6–9.3) and the median absolute neutrophil (ANC) nadir was 2.0 × 103/μl (range 0.4–7.2). Thrombocytopenia - 100.0 × 103/μl was observed in 15 patients; the median platelet nadir was 123.0 (range 30.0–245.0). All patients experienced a mild to moderate flu-like syndrome. In addition, one patient had a mild hemolytic-uremic syndrome which appeared related to gemcitabine therapy. Gemcitabine demonstrated marginal activity in this resistant neoplasm, without excessive toxicity. Further evaluation, including the use of more intense dosing and/or combination therapy, is warranted.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1007/BF00873232

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4

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Phase II trial of carboplatin in patients with advanced melanoma (1990)

Casper, Ephraim S. ; Bajorin, Dean

Springer

Investigational new drugs 8 (1990), S. 187-190

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ISSN: 1573-0646

Keywords: carboplatin ; melanoma

Source: Springer Online Journal Archives 1860-2000

Topics: Chemistry and Pharmacology , Medicine

Notes: Summary We report the results of a phase II evaluation of carboplatin (CBDCA) in 45 patients with advanced malignant melanoma. Of the 43 evaluable patients, 6 had been treated previously with chemotherapy; 11 had been treated with immunotherapy. The initial dose was 400 mg/m2 i.v. every 4 weeks; the dose was modified as required to achieve moderate myelosuppression. There was one complete response (duration 16 months) and six partial responses, for a major objective response rate of 16%. Toxicity consisted primarily of acute nausea and vomiting, and thrombocytopenia. The activity of CBDCA in this disease is similar to that of cisplatin and dacarbazine.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1007/BF00177256

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5

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Phase II trial of edatrexate in patients with advanced pancreatic adenocarcinoma (1992)

Casper, Ephraim S. ; Schwartz, Gary K. ; Johnson, Bruce ; [et al.]

Springer

Investigational new drugs 10 (1992), S. 313-316

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ISSN: 1573-0646

Keywords: phase II ; edatrexate ; adenocarcinoma ; pancreas

Source: Springer Online Journal Archives 1860-2000

Topics: Chemistry and Pharmacology , Medicine

Notes: Abstract We conducted a phase II evaluation of edatrexate in 17 previously untreated patients with advanced adenocarcinoma of the pancreas; 14 patients had at least one month of therapy. The initial dose was 80 mg/m2iv. Treatment was administered weekly for 5 weeks, then every other week. Toxicity was generally mild. The median WBC nadir was 5.4 (range 0.6–7.4)×103/μl, and the median platelet nadir was 164.0 (range 62.0–341.0)×103/μl. One patient died with sepsis and gastrointestinal bleeding associated with pancytopenia. Five patients had a mild rash. Nausea occurred in 6 patients, including 3 who had vomiting. In addition, 11 patients complained of vague malaise which seemed to begin within 24–48 hours after administration of edatrexate, and lasted for 2 to 3 days, resolving within 6 days of drug administration. Median survival was 85 days. Although 5 patients had stable disease, including one with relief of pain, no major responses were seen, excluding, with 95% confidence, a response rate in excess of 20%.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1007/BF00944187

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6

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Phase II trial of ZD1694 (TomudexTM) in patients with advanced pancreatic cancer (1995)

Pazdur, Richard ; Meropol, Neal J. ; Casper, Ephraim S. ; [et al.]

Springer

Investigational new drugs 13 (1995), S. 355-358

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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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7

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Phase I clinical trial of doxorubicin and iproplatin combination chemotherapy in patients with breast cancer (1989)

Casper, Ephraim S. ; Curley, Tracy ; Hakes, Thomas B.

Springer

Investigational new drugs 7 (1989), S. 189-193

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ISSN: 1573-0646

Keywords: doxorubicin ; iproplatin ; breast cancer

Source: Springer Online Journal Archives 1860-2000

Topics: Chemistry and Pharmacology , Medicine

Notes: Summary Forty-eight patients with advanced breast cancer were treated in a disease-specific phase I trial of doxorubicin and iproplatin combination chemotherapy. The doses of doxorubicin ranged between 30 and 50 mg/m2, and the doses of iproplatin ranged between 150 and 250 mg/m2. Myelosuppression was observed at all levels, but was dose-limiting at the highest level. In addition, nausea, diarrhea and malaise were prominent toxicities. Neither cardiac nor renal toxicity was encountered. Nine of 26 (35%) of previously untreated patients, and 5 of 22 (23%) previously treated patients demonstrated partial or complete responses. Although this combination possesses therapeutic activity, given its toxicities, further evaluation of doxorubicin in combination with iproplatin is not recommended.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1007/BF00170856

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8

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Clinical trial of iproplatin (cis-dichloro-trans-dihydroxy-bis-isopropylamine platinum IV, CHIP) in patients with advanced breast cancer (1988)

Casper, Ephraim S. ; Smart, Tracy C. ; Hakes, Thomas B. ; [et al.]

Springer

Investigational new drugs 6 (1988), S. 87-91

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ISSN: 1573-0646

Keywords: breast cancer ; Iproplatin ; CHIP ; phase II study

Source: Springer Online Journal Archives 1860-2000

Topics: Chemistry and Pharmacology , Medicine

Notes: Summary Twenty-five women with advanced breast cancer were treated in a phase II trial of iproplatin 275 mg/m2 administered intravenously every 4 weeks. All patients had measurable or evaluable indicator lesions, and had undergone treatment with no more than one previous chemotherapy regimen, including adjuvant chemotherapy. Two of the twenty-four evaluable patients (8%) experienced major therapeutic responses. One patient had a complete regression of pulmonary nodules lasting 18 + months; another had a partial regression of metastatic disease in the liver (4 months). The inevaluable patient was ineligible for the study because of previous radiation to the indicator lesions on her chest wall; nonetheless, she experienced a 10 month partial regression of those nodules. Myelosuppression was generally dose limiting; thrombocytopenia was more profound, but leukopenia was more prolonged. Nausea, vomiting, diarrhea, and general malaise were prominent toxicities, and led to discontinuation of therapy in 4 patients. Iproplatin has limited activity in previously treated women with advanced breast cancer.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1007/BF00195365

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