Phase I Dose-finding and Pharmacokinetic Trial of Irinotecan Hydrochloride (CPT-11) Using a Once-Every-Three-Week Dosing Schedule for Patients with Advanced Solid Tumor Malignancy

A Phase I study was performed to determine the maximum tolerated dose (MTD), toxicities, and pharmacokinetic profile of irinotecan (CPT-11) and its active metabolites when given on a once-every-3-week schedule. Thirty-four patients with advanced refractory solid malignancies were treated with CPT-11...

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Veröffentlicht in:Clinical cancer research 2000-06, Vol.6 (6), p.2236
Hauptverfasser: Pitot, H C, Goldberg, R M, Reid, J M, Sloan, J A, Skaff, P A, Erlichman, C, Rubin, J, Burch, P A, Adjei, A A, Alberts, S A, Schaaf, L J, Elfring, G, Miller, L L
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container_issue 6
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container_title Clinical cancer research
container_volume 6
creator Pitot, H C
Goldberg, R M
Reid, J M
Sloan, J A
Skaff, P A
Erlichman, C
Rubin, J
Burch, P A
Adjei, A A
Alberts, S A
Schaaf, L J
Elfring, G
Miller, L L
description A Phase I study was performed to determine the maximum tolerated dose (MTD), toxicities, and pharmacokinetic profile of irinotecan (CPT-11) and its active metabolites when given on a once-every-3-week schedule. Thirty-four patients with advanced refractory solid malignancies were treated with CPT-11 (240–340 mg/m 2 ) administered as a 90-min i.v. infusion every 3 weeks. Patients were divided into two groups: those with and those without prior abdominal/pelvic (AP) radiotherapy. Gastrointestinal toxicity (nausea, vomiting, and diarrhea) and hematological toxicity (leukopenia and neutropenia) were dose-limiting side effects. Other common toxicities included anorexia, asthenia, and acute cholinergic symptoms (abdominal cramps, diaphoresis, and lacrimation). For patients with no prior AP radiation therapy, the MTD was determined to be 320 mg/m 2 , whereas those with prior AP radiation therapy had a MTD of 290 mg/m 2 . Dose-proportional increases in the mean area under the concentration-time curves for CPT-11, SN-38, and SN-38G were not observed over the narrow dose range studied. Mean values of terminal phase half-life, clearance, terminal phase volume of distribution, and steady-state volume of distribution for CPT-11 were 12.4 ± 1.8 h, 13.0 ± 3.8 liters/h/m 2 , 234 ± 83 liters/m 2 , and 123 ± 38 liters/m 2 , respectively. The pharmacodynamic analyses indicated the strongest correlation to be between SN-38 area under the concentration-time curves and neutropenia (ρ = 0.60; P = 0.001). A total of five responses (one complete response and four partial responses) were observed in the cohort of 32 patients with previously treated metastatic colorectal carcinoma. In conclusion, gastrointestinal toxicity and hematological toxicity were the dose-limiting toxicities of CPT-11 when administered as a 90-min infusion every 3 weeks. In this trial, the recommended Phase II starting dose for patients with no prior AP radiation therapy was found to be 320 mg/m 2 ; for patients with prior AP radiation, the recommended Phase II starting dose was 290 mg/m 2 . This once-every-3-week schedule has been incorporated into a Phase I trial of CPT-11 combined with 5-fluorouracil and leucovorin.
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Thirty-four patients with advanced refractory solid malignancies were treated with CPT-11 (240–340 mg/m 2 ) administered as a 90-min i.v. infusion every 3 weeks. Patients were divided into two groups: those with and those without prior abdominal/pelvic (AP) radiotherapy. Gastrointestinal toxicity (nausea, vomiting, and diarrhea) and hematological toxicity (leukopenia and neutropenia) were dose-limiting side effects. Other common toxicities included anorexia, asthenia, and acute cholinergic symptoms (abdominal cramps, diaphoresis, and lacrimation). For patients with no prior AP radiation therapy, the MTD was determined to be 320 mg/m 2 , whereas those with prior AP radiation therapy had a MTD of 290 mg/m 2 . Dose-proportional increases in the mean area under the concentration-time curves for CPT-11, SN-38, and SN-38G were not observed over the narrow dose range studied. Mean values of terminal phase half-life, clearance, terminal phase volume of distribution, and steady-state volume of distribution for CPT-11 were 12.4 ± 1.8 h, 13.0 ± 3.8 liters/h/m 2 , 234 ± 83 liters/m 2 , and 123 ± 38 liters/m 2 , respectively. The pharmacodynamic analyses indicated the strongest correlation to be between SN-38 area under the concentration-time curves and neutropenia (ρ = 0.60; P = 0.001). A total of five responses (one complete response and four partial responses) were observed in the cohort of 32 patients with previously treated metastatic colorectal carcinoma. In conclusion, gastrointestinal toxicity and hematological toxicity were the dose-limiting toxicities of CPT-11 when administered as a 90-min infusion every 3 weeks. In this trial, the recommended Phase II starting dose for patients with no prior AP radiation therapy was found to be 320 mg/m 2 ; for patients with prior AP radiation, the recommended Phase II starting dose was 290 mg/m 2 . 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Thirty-four patients with advanced refractory solid malignancies were treated with CPT-11 (240–340 mg/m 2 ) administered as a 90-min i.v. infusion every 3 weeks. Patients were divided into two groups: those with and those without prior abdominal/pelvic (AP) radiotherapy. Gastrointestinal toxicity (nausea, vomiting, and diarrhea) and hematological toxicity (leukopenia and neutropenia) were dose-limiting side effects. Other common toxicities included anorexia, asthenia, and acute cholinergic symptoms (abdominal cramps, diaphoresis, and lacrimation). For patients with no prior AP radiation therapy, the MTD was determined to be 320 mg/m 2 , whereas those with prior AP radiation therapy had a MTD of 290 mg/m 2 . Dose-proportional increases in the mean area under the concentration-time curves for CPT-11, SN-38, and SN-38G were not observed over the narrow dose range studied. Mean values of terminal phase half-life, clearance, terminal phase volume of distribution, and steady-state volume of distribution for CPT-11 were 12.4 ± 1.8 h, 13.0 ± 3.8 liters/h/m 2 , 234 ± 83 liters/m 2 , and 123 ± 38 liters/m 2 , respectively. The pharmacodynamic analyses indicated the strongest correlation to be between SN-38 area under the concentration-time curves and neutropenia (ρ = 0.60; P = 0.001). A total of five responses (one complete response and four partial responses) were observed in the cohort of 32 patients with previously treated metastatic colorectal carcinoma. In conclusion, gastrointestinal toxicity and hematological toxicity were the dose-limiting toxicities of CPT-11 when administered as a 90-min infusion every 3 weeks. In this trial, the recommended Phase II starting dose for patients with no prior AP radiation therapy was found to be 320 mg/m 2 ; for patients with prior AP radiation, the recommended Phase II starting dose was 290 mg/m 2 . 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Goldberg, R M ; Reid, J M ; Sloan, J A ; Skaff, P A ; Erlichman, C ; Rubin, J ; Burch, P A ; Adjei, A A ; Alberts, S A ; Schaaf, L J ; Elfring, G ; Miller, L L</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-h239t-9f9fee5bcd38f788f7bc2a8f8b3148b6fd4b58c31ff78dc9ebf647f3c7cd1bb83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2000</creationdate><topic>Adjuvants, Anesthesia - pharmacology</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antidiarrheals - pharmacology</topic><topic>Antiemetics - pharmacology</topic><topic>Antineoplastic Agents, Phytogenic - blood</topic><topic>Antineoplastic Agents, Phytogenic - pharmacokinetics</topic><topic>Antineoplastic Agents, Phytogenic - therapeutic use</topic><topic>Antineoplastic Agents, Phytogenic - toxicity</topic><topic>Area Under Curve</topic><topic>Atropine - pharmacology</topic><topic>Camptothecin - analogs &amp; derivatives</topic><topic>Camptothecin - blood</topic><topic>Camptothecin - pharmacokinetics</topic><topic>Camptothecin - therapeutic use</topic><topic>Camptothecin - toxicity</topic><topic>Colorectal Neoplasms - drug therapy</topic><topic>Dexamethasone - pharmacology</topic><topic>Digestive System - drug effects</topic><topic>Dose-Response Relationship, Drug</topic><topic>Esophageal Neoplasms - drug therapy</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Gallbladder Neoplasms - drug therapy</topic><topic>Glucuronates - blood</topic><topic>Glucuronates - pharmacokinetics</topic><topic>Humans</topic><topic>Loperamide - pharmacology</topic><topic>Male</topic><topic>Maximum Tolerated Dose</topic><topic>Middle Aged</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pitot, H C</creatorcontrib><creatorcontrib>Goldberg, R M</creatorcontrib><creatorcontrib>Reid, J M</creatorcontrib><creatorcontrib>Sloan, J A</creatorcontrib><creatorcontrib>Skaff, P A</creatorcontrib><creatorcontrib>Erlichman, C</creatorcontrib><creatorcontrib>Rubin, J</creatorcontrib><creatorcontrib>Burch, P A</creatorcontrib><creatorcontrib>Adjei, A A</creatorcontrib><creatorcontrib>Alberts, S A</creatorcontrib><creatorcontrib>Schaaf, L J</creatorcontrib><creatorcontrib>Elfring, G</creatorcontrib><creatorcontrib>Miller, L L</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><jtitle>Clinical cancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pitot, H C</au><au>Goldberg, R M</au><au>Reid, J M</au><au>Sloan, J A</au><au>Skaff, P A</au><au>Erlichman, C</au><au>Rubin, J</au><au>Burch, P A</au><au>Adjei, A A</au><au>Alberts, S A</au><au>Schaaf, L J</au><au>Elfring, G</au><au>Miller, L L</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase I Dose-finding and Pharmacokinetic Trial of Irinotecan Hydrochloride (CPT-11) Using a Once-Every-Three-Week Dosing Schedule for Patients with Advanced Solid Tumor Malignancy</atitle><jtitle>Clinical cancer research</jtitle><addtitle>Clin Cancer Res</addtitle><date>2000-06-01</date><risdate>2000</risdate><volume>6</volume><issue>6</issue><spage>2236</spage><pages>2236-</pages><issn>1078-0432</issn><eissn>1557-3265</eissn><abstract>A Phase I study was performed to determine the maximum tolerated dose (MTD), toxicities, and pharmacokinetic profile of irinotecan (CPT-11) and its active metabolites when given on a once-every-3-week schedule. Thirty-four patients with advanced refractory solid malignancies were treated with CPT-11 (240–340 mg/m 2 ) administered as a 90-min i.v. infusion every 3 weeks. Patients were divided into two groups: those with and those without prior abdominal/pelvic (AP) radiotherapy. Gastrointestinal toxicity (nausea, vomiting, and diarrhea) and hematological toxicity (leukopenia and neutropenia) were dose-limiting side effects. Other common toxicities included anorexia, asthenia, and acute cholinergic symptoms (abdominal cramps, diaphoresis, and lacrimation). For patients with no prior AP radiation therapy, the MTD was determined to be 320 mg/m 2 , whereas those with prior AP radiation therapy had a MTD of 290 mg/m 2 . Dose-proportional increases in the mean area under the concentration-time curves for CPT-11, SN-38, and SN-38G were not observed over the narrow dose range studied. Mean values of terminal phase half-life, clearance, terminal phase volume of distribution, and steady-state volume of distribution for CPT-11 were 12.4 ± 1.8 h, 13.0 ± 3.8 liters/h/m 2 , 234 ± 83 liters/m 2 , and 123 ± 38 liters/m 2 , respectively. The pharmacodynamic analyses indicated the strongest correlation to be between SN-38 area under the concentration-time curves and neutropenia (ρ = 0.60; P = 0.001). A total of five responses (one complete response and four partial responses) were observed in the cohort of 32 patients with previously treated metastatic colorectal carcinoma. In conclusion, gastrointestinal toxicity and hematological toxicity were the dose-limiting toxicities of CPT-11 when administered as a 90-min infusion every 3 weeks. In this trial, the recommended Phase II starting dose for patients with no prior AP radiation therapy was found to be 320 mg/m 2 ; for patients with prior AP radiation, the recommended Phase II starting dose was 290 mg/m 2 . This once-every-3-week schedule has been incorporated into a Phase I trial of CPT-11 combined with 5-fluorouracil and leucovorin.</abstract><cop>United States</cop><pub>American Association for Cancer Research</pub><pmid>10873073</pmid></addata></record>
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source MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; American Association for Cancer Research; Alma/SFX Local Collection
subjects Adjuvants, Anesthesia - pharmacology
Adult
Aged
Aged, 80 and over
Antidiarrheals - pharmacology
Antiemetics - pharmacology
Antineoplastic Agents, Phytogenic - blood
Antineoplastic Agents, Phytogenic - pharmacokinetics
Antineoplastic Agents, Phytogenic - therapeutic use
Antineoplastic Agents, Phytogenic - toxicity
Area Under Curve
Atropine - pharmacology
Camptothecin - analogs & derivatives
Camptothecin - blood
Camptothecin - pharmacokinetics
Camptothecin - therapeutic use
Camptothecin - toxicity
Colorectal Neoplasms - drug therapy
Dexamethasone - pharmacology
Digestive System - drug effects
Dose-Response Relationship, Drug
Esophageal Neoplasms - drug therapy
Female
Follow-Up Studies
Gallbladder Neoplasms - drug therapy
Glucuronates - blood
Glucuronates - pharmacokinetics
Humans
Loperamide - pharmacology
Male
Maximum Tolerated Dose
Middle Aged
Time Factors
title Phase I Dose-finding and Pharmacokinetic Trial of Irinotecan Hydrochloride (CPT-11) Using a Once-Every-Three-Week Dosing Schedule for Patients with Advanced Solid Tumor Malignancy
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