Phase I clinical and pharmacokinetic study of an one-hour infusion of ormaplatin (NSC 363812)
Tutsch, Kendra D. ; Arzoomanian, Rhoda Z. ; Alberti, Dona ; Tombes, Mary B. ; Feierabend, Christine ; Robins, H. Ian ; Spriggs, David R. ; Wilding, George
Springer
Published 1999
Springer
Published 1999
| ISSN: |
1573-0646
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|---|---|
| Keywords: |
chemotherapy ; platinum (IV) analogues ; cisplatin resistance ; pharmacodynamics
|
| Source: |
Springer Online Journal Archives 1860-2000
|
| Topics: |
Chemistry and Pharmacology
Medicine
|
| Notes: |
Abstract Ormaplatin (NSC 363812, tetraplatin) is a stable platinum (IV) analog which has exhibited activity against cisplatin-resistant cell lines. A phase I trial of ormaplatin administered as a 1-h infusion every 4 weeks was performed. Forty-one patients received 101 cycles of drug over the dose range 4–128 mg/m2. The dose-limiting toxicity was reversible thrombocytopenia and granulocytopenia. Minimal myelosuppression was observed at dose levels ≤ 78 mg/m2, while grade 3 or 4 myelosuppression (thrombocytopenia and/or granulocytopenia) was seen in 4/8 patients at 98 mg/m2 and 4/5 patients at 123 mg/m2. Nausea and vomiting was observed at all dose levels but was controlled with antiemetic premedication. Neurotoxicity was observed in 5/41 patients and the incidence appeared related to cumulative dose rather than to dose level or drug clearance. Platinum was measured by furnace atomic absorption spectrophotometry. Ormaplatin-derived plasma ultrafilterable platinum (UF-Pt) exhibited linear pharmacokinetics over the dose range studied. The mean total body clearance of UF-Pt was 135 ml/min/m2 and the mean elimination half-life (t1/2β) was 13.6 h. Ormaplatin exhibited a high degree of protein binding, with more than 70% of platinum protein bound by the end of the infusion. Urinary excretion of platinum accounted for 37% of the total dose of ormaplatin in 24 hours. A phase II dose of 98 mg/m2 is recommended for testing in a patient population with cisplatin-refractory disease.
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| Type of Medium: |
Electronic Resource
|
| URL: |
| _version_ | 1798297438775148545 |
|---|---|
| autor | Tutsch, Kendra D. Arzoomanian, Rhoda Z. Alberti, Dona Tombes, Mary B. Feierabend, Christine Robins, H. Ian Spriggs, David R. Wilding, George |
| autorsonst | Tutsch, Kendra D. Arzoomanian, Rhoda Z. Alberti, Dona Tombes, Mary B. Feierabend, Christine Robins, H. Ian Spriggs, David R. Wilding, George |
| book_url | http://dx.doi.org/10.1023/A:1006223100561 |
| datenlieferant | nat_lic_papers |
| hauptsatz | hsatz_simple |
| identnr | NLM197072186 |
| issn | 1573-0646 |
| journal_name | Investigational new drugs |
| materialart | 1 |
| notes | Abstract Ormaplatin (NSC 363812, tetraplatin) is a stable platinum (IV) analog which has exhibited activity against cisplatin-resistant cell lines. A phase I trial of ormaplatin administered as a 1-h infusion every 4 weeks was performed. Forty-one patients received 101 cycles of drug over the dose range 4–128 mg/m2. The dose-limiting toxicity was reversible thrombocytopenia and granulocytopenia. Minimal myelosuppression was observed at dose levels ≤ 78 mg/m2, while grade 3 or 4 myelosuppression (thrombocytopenia and/or granulocytopenia) was seen in 4/8 patients at 98 mg/m2 and 4/5 patients at 123 mg/m2. Nausea and vomiting was observed at all dose levels but was controlled with antiemetic premedication. Neurotoxicity was observed in 5/41 patients and the incidence appeared related to cumulative dose rather than to dose level or drug clearance. Platinum was measured by furnace atomic absorption spectrophotometry. Ormaplatin-derived plasma ultrafilterable platinum (UF-Pt) exhibited linear pharmacokinetics over the dose range studied. The mean total body clearance of UF-Pt was 135 ml/min/m2 and the mean elimination half-life (t1/2β) was 13.6 h. Ormaplatin exhibited a high degree of protein binding, with more than 70% of platinum protein bound by the end of the infusion. Urinary excretion of platinum accounted for 37% of the total dose of ormaplatin in 24 hours. A phase II dose of 98 mg/m2 is recommended for testing in a patient population with cisplatin-refractory disease. |
| package_name | Springer |
| publikationsjahr_anzeige | 1999 |
| publikationsjahr_facette | 1999 |
| publikationsjahr_intervall | 8004:1995-1999 |
| publikationsjahr_sort | 1999 |
| publisher | Springer |
| reference | 17 (1999), S. 63-72 |
| schlagwort | chemotherapy platinum (IV) analogues cisplatin resistance pharmacodynamics |
| search_space | articles |
| shingle_author_1 | Tutsch, Kendra D. Arzoomanian, Rhoda Z. Alberti, Dona Tombes, Mary B. Feierabend, Christine Robins, H. Ian Spriggs, David R. Wilding, George |
| shingle_author_2 | Tutsch, Kendra D. Arzoomanian, Rhoda Z. Alberti, Dona Tombes, Mary B. Feierabend, Christine Robins, H. Ian Spriggs, David R. Wilding, George |
| shingle_author_3 | Tutsch, Kendra D. Arzoomanian, Rhoda Z. Alberti, Dona Tombes, Mary B. Feierabend, Christine Robins, H. Ian Spriggs, David R. Wilding, George |
| shingle_author_4 | Tutsch, Kendra D. Arzoomanian, Rhoda Z. Alberti, Dona Tombes, Mary B. Feierabend, Christine Robins, H. Ian Spriggs, David R. Wilding, George |
| shingle_catch_all_1 | Tutsch, Kendra D. Arzoomanian, Rhoda Z. Alberti, Dona Tombes, Mary B. Feierabend, Christine Robins, H. Ian Spriggs, David R. Wilding, George Phase I clinical and pharmacokinetic study of an one-hour infusion of ormaplatin (NSC 363812) chemotherapy platinum (IV) analogues cisplatin resistance pharmacodynamics chemotherapy platinum (IV) analogues cisplatin resistance pharmacodynamics Abstract Ormaplatin (NSC 363812, tetraplatin) is a stable platinum (IV) analog which has exhibited activity against cisplatin-resistant cell lines. A phase I trial of ormaplatin administered as a 1-h infusion every 4 weeks was performed. Forty-one patients received 101 cycles of drug over the dose range 4–128 mg/m2. The dose-limiting toxicity was reversible thrombocytopenia and granulocytopenia. Minimal myelosuppression was observed at dose levels ≤ 78 mg/m2, while grade 3 or 4 myelosuppression (thrombocytopenia and/or granulocytopenia) was seen in 4/8 patients at 98 mg/m2 and 4/5 patients at 123 mg/m2. Nausea and vomiting was observed at all dose levels but was controlled with antiemetic premedication. Neurotoxicity was observed in 5/41 patients and the incidence appeared related to cumulative dose rather than to dose level or drug clearance. Platinum was measured by furnace atomic absorption spectrophotometry. Ormaplatin-derived plasma ultrafilterable platinum (UF-Pt) exhibited linear pharmacokinetics over the dose range studied. The mean total body clearance of UF-Pt was 135 ml/min/m2 and the mean elimination half-life (t1/2β) was 13.6 h. Ormaplatin exhibited a high degree of protein binding, with more than 70% of platinum protein bound by the end of the infusion. Urinary excretion of platinum accounted for 37% of the total dose of ormaplatin in 24 hours. A phase II dose of 98 mg/m2 is recommended for testing in a patient population with cisplatin-refractory disease. 1573-0646 15730646 Springer |
| shingle_catch_all_2 | Tutsch, Kendra D. Arzoomanian, Rhoda Z. Alberti, Dona Tombes, Mary B. Feierabend, Christine Robins, H. Ian Spriggs, David R. Wilding, George Phase I clinical and pharmacokinetic study of an one-hour infusion of ormaplatin (NSC 363812) chemotherapy platinum (IV) analogues cisplatin resistance pharmacodynamics chemotherapy platinum (IV) analogues cisplatin resistance pharmacodynamics Abstract Ormaplatin (NSC 363812, tetraplatin) is a stable platinum (IV) analog which has exhibited activity against cisplatin-resistant cell lines. A phase I trial of ormaplatin administered as a 1-h infusion every 4 weeks was performed. Forty-one patients received 101 cycles of drug over the dose range 4–128 mg/m2. The dose-limiting toxicity was reversible thrombocytopenia and granulocytopenia. Minimal myelosuppression was observed at dose levels ≤ 78 mg/m2, while grade 3 or 4 myelosuppression (thrombocytopenia and/or granulocytopenia) was seen in 4/8 patients at 98 mg/m2 and 4/5 patients at 123 mg/m2. Nausea and vomiting was observed at all dose levels but was controlled with antiemetic premedication. Neurotoxicity was observed in 5/41 patients and the incidence appeared related to cumulative dose rather than to dose level or drug clearance. Platinum was measured by furnace atomic absorption spectrophotometry. Ormaplatin-derived plasma ultrafilterable platinum (UF-Pt) exhibited linear pharmacokinetics over the dose range studied. The mean total body clearance of UF-Pt was 135 ml/min/m2 and the mean elimination half-life (t1/2β) was 13.6 h. Ormaplatin exhibited a high degree of protein binding, with more than 70% of platinum protein bound by the end of the infusion. Urinary excretion of platinum accounted for 37% of the total dose of ormaplatin in 24 hours. A phase II dose of 98 mg/m2 is recommended for testing in a patient population with cisplatin-refractory disease. 1573-0646 15730646 Springer |
| shingle_catch_all_3 | Tutsch, Kendra D. Arzoomanian, Rhoda Z. Alberti, Dona Tombes, Mary B. Feierabend, Christine Robins, H. Ian Spriggs, David R. Wilding, George Phase I clinical and pharmacokinetic study of an one-hour infusion of ormaplatin (NSC 363812) chemotherapy platinum (IV) analogues cisplatin resistance pharmacodynamics chemotherapy platinum (IV) analogues cisplatin resistance pharmacodynamics Abstract Ormaplatin (NSC 363812, tetraplatin) is a stable platinum (IV) analog which has exhibited activity against cisplatin-resistant cell lines. A phase I trial of ormaplatin administered as a 1-h infusion every 4 weeks was performed. Forty-one patients received 101 cycles of drug over the dose range 4–128 mg/m2. The dose-limiting toxicity was reversible thrombocytopenia and granulocytopenia. Minimal myelosuppression was observed at dose levels ≤ 78 mg/m2, while grade 3 or 4 myelosuppression (thrombocytopenia and/or granulocytopenia) was seen in 4/8 patients at 98 mg/m2 and 4/5 patients at 123 mg/m2. Nausea and vomiting was observed at all dose levels but was controlled with antiemetic premedication. Neurotoxicity was observed in 5/41 patients and the incidence appeared related to cumulative dose rather than to dose level or drug clearance. Platinum was measured by furnace atomic absorption spectrophotometry. Ormaplatin-derived plasma ultrafilterable platinum (UF-Pt) exhibited linear pharmacokinetics over the dose range studied. The mean total body clearance of UF-Pt was 135 ml/min/m2 and the mean elimination half-life (t1/2β) was 13.6 h. Ormaplatin exhibited a high degree of protein binding, with more than 70% of platinum protein bound by the end of the infusion. Urinary excretion of platinum accounted for 37% of the total dose of ormaplatin in 24 hours. A phase II dose of 98 mg/m2 is recommended for testing in a patient population with cisplatin-refractory disease. 1573-0646 15730646 Springer |
| shingle_catch_all_4 | Tutsch, Kendra D. Arzoomanian, Rhoda Z. Alberti, Dona Tombes, Mary B. Feierabend, Christine Robins, H. Ian Spriggs, David R. Wilding, George Phase I clinical and pharmacokinetic study of an one-hour infusion of ormaplatin (NSC 363812) chemotherapy platinum (IV) analogues cisplatin resistance pharmacodynamics chemotherapy platinum (IV) analogues cisplatin resistance pharmacodynamics Abstract Ormaplatin (NSC 363812, tetraplatin) is a stable platinum (IV) analog which has exhibited activity against cisplatin-resistant cell lines. A phase I trial of ormaplatin administered as a 1-h infusion every 4 weeks was performed. Forty-one patients received 101 cycles of drug over the dose range 4–128 mg/m2. The dose-limiting toxicity was reversible thrombocytopenia and granulocytopenia. Minimal myelosuppression was observed at dose levels ≤ 78 mg/m2, while grade 3 or 4 myelosuppression (thrombocytopenia and/or granulocytopenia) was seen in 4/8 patients at 98 mg/m2 and 4/5 patients at 123 mg/m2. Nausea and vomiting was observed at all dose levels but was controlled with antiemetic premedication. Neurotoxicity was observed in 5/41 patients and the incidence appeared related to cumulative dose rather than to dose level or drug clearance. Platinum was measured by furnace atomic absorption spectrophotometry. Ormaplatin-derived plasma ultrafilterable platinum (UF-Pt) exhibited linear pharmacokinetics over the dose range studied. The mean total body clearance of UF-Pt was 135 ml/min/m2 and the mean elimination half-life (t1/2β) was 13.6 h. Ormaplatin exhibited a high degree of protein binding, with more than 70% of platinum protein bound by the end of the infusion. Urinary excretion of platinum accounted for 37% of the total dose of ormaplatin in 24 hours. A phase II dose of 98 mg/m2 is recommended for testing in a patient population with cisplatin-refractory disease. 1573-0646 15730646 Springer |
| shingle_title_1 | Phase I clinical and pharmacokinetic study of an one-hour infusion of ormaplatin (NSC 363812) |
| shingle_title_2 | Phase I clinical and pharmacokinetic study of an one-hour infusion of ormaplatin (NSC 363812) |
| shingle_title_3 | Phase I clinical and pharmacokinetic study of an one-hour infusion of ormaplatin (NSC 363812) |
| shingle_title_4 | Phase I clinical and pharmacokinetic study of an one-hour infusion of ormaplatin (NSC 363812) |
| sigel_instance_filter | dkfz geomar wilbert ipn albert fhp |
| source_archive | Springer Online Journal Archives 1860-2000 |
| timestamp | 2024-05-06T10:07:59.934Z |
| titel | Phase I clinical and pharmacokinetic study of an one-hour infusion of ormaplatin (NSC 363812) |
| titel_suche | Phase I clinical and pharmacokinetic study of an one-hour infusion of ormaplatin (NSC 363812) |
| topic | V WW-YZ |
| uid | nat_lic_papers_NLM197072186 |