Phase I Dose Escalation Study of Gemcitabine plus Irinotecan in Advanced Solid Tumors

被引：0

作者：

Dugan, Elizabeth ^{[1
]}

Truax, Roxanne ^{[1
]}

Meadows, Kellen L. ^{[1
]}

Blobe, Gerald C. ^{[1
]}

Morse, Michael A. ^{[1
]}

Fernando, Nishan H. ^{[1
]}

Gockerman, Jon P. ^{[1
]}

Petros, William P. ^{[2
]}

Hurwitz, Herbert I. ^{[1
]}

机构：

[1] Duke Univ, Med Ctr, Durham, NC 27710 USA

[2] W Virginia Univ, Mary Babb Randolph Canc Ctr, Morgantown, WV 26506 USA

来源：

ANTICANCER RESEARCH | 2009年 / 29卷 / 12期

关键词：

Gemcitabine; irinotecan; phase I; advanced solid tumors; CELL LUNG-CANCER; PANCREATIC-CANCER; COMBINATION CHEMOTHERAPY; COLORECTAL-CANCER; CLINICAL ACTIVITY; CPT-11; TRIAL; BREAST;

D O I：

暂无

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Aim: To determine the maximally tolerated dose (MTD), recommended phase 11 dose (RPTD) and toxicity profile of gemcitabine plus irinotecan combination. Patients and Methods: Thirty-nine evaluable patients with advanced solid tumors were treated with gemcitabine (Gem) and irinotecan (Iri) on days 1, 8 and 15 of a 28-day cycle. Dose levels included Gem/Iri 700150, 900150, 900175, 500150 mg/m(2) respectively. Dose-limiting toxicity (DLT) was assessed during cycle one; toxicity evaluation was closely monitored throughout the course of treatment. Treatment continued until disease progression or unacceptable toxicity. Results: DLTs primarily consisted of grade >= 3 thrombocytopenia lasting 24 days often accompanied by grade >= 3 neutropenia. Other grade >= 3 toxicities included vomiting, diarrhea, fatigue and elevated alkaline phosphatase. Three patients had a partial response. Stable disease as best response was seen in 16 patients, ranging from 2-18 months. Conclusion: The MTD/RPTD is gemcitabine 500 mg/m(2) phis irinotecan 50 mg/m(2) on days 1, 8 and 15 of a 28-day cycle. Given the toxicity profile and negative results of phase III studies, no further testing of this treatment combination is recommended.

引用

页码：5149 / 5153

页数：5

共 23 条

[1] Phase I trial of gemcitabine and CPT-11 given weekly for four weeks every six weeks [J].