scholarly journals Recombinant human endostatin administered as a 28-day continuous intravenous infusion, followed by daily subcutaneous injections: a phase I and pharmacokinetic study in patients with advanced cancer

2005 ◽  
Vol 16 (10) ◽  
pp. 1695-1701 ◽  
Author(s):  
A.H.G. Hansma ◽  
H.J. Broxterman ◽  
I. van der Horst ◽  
Y. Yuana ◽  
E. Boven ◽  
...  
Keyword(s):  
Phase I ◽  
Advanced Cancer ◽  
Pharmacokinetic Study ◽  
Intravenous Infusion ◽  
Continuous Intravenous Infusion ◽  
Recombinant Human Endostatin ◽  
Subcutaneous Injections

A phase I clinical and pharmacokinetic study of the dolastatin analogue cemadotin administered as a 5-day continuous intravenous infusion

2000 ◽  
Vol 46 (4) ◽  
pp. 319-328 ◽  
Author(s):  
Jeffrey G. Supko ◽  
Thomas J. Lynch ◽  
Jeffrey W. Clark ◽  
Robert Fram ◽  
Lee F. Allen ◽  
...  
Keyword(s):  
Phase I ◽  
Pharmacokinetic Study ◽  
Intravenous Infusion ◽  
Continuous Intravenous Infusion

Phase I clinical and pharmacokinetic study of cyclophosphamide administered by five-day continuous intravenous infusion

1986 ◽  
Vol 18 (1) ◽  
pp. 33-38 ◽  
Author(s):  
N. Simon Tchekmedyian ◽  
Merrill J. Egorin ◽  
Brian E. Cohen ◽  
Richard S. Kaplan ◽  
Elizabeth Poplin ◽  
...  
Keyword(s):  
Phase I ◽  
Pharmacokinetic Study ◽  
Intravenous Infusion ◽  
Continuous Intravenous Infusion

Phase I to II Multicenter Study of Oblimersen Sodium, a Bcl-2 Antisense Oligonucleotide, in Patients With Advanced Chronic Lymphocytic Leukemia

2005 ◽  
Vol 23 (30) ◽  
pp. 7697-7702 ◽  
Author(s):  
Susan M. O'Brien ◽  
Charles C. Cunningham ◽  
Anatoliy K. Golenkov ◽  
Anna G. Turkina ◽  
Steven C. Novick ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Phase I ◽  
Phase Ii ◽  
Intravenous Infusion ◽  
Single Agent ◽  
Plasma Concentrations ◽  
Parent Drug ◽  
Lymphocytic Leukemia ◽  
Complete Disappearance ◽  
Continuous Intravenous Infusion

Purpose To determine the maximum-tolerated dose (MTD), efficacy, safety, and pharmacokinetics of oblimersen sodium in patients with advanced chronic lymphocytic leukemia (CLL). Patients and Methods Eligible patients had relapsed or refractory CLL after treatment with fludarabine. Oblimersen was administered at doses ranging from 3 to 7 mg/kg/d as a 5-day continuous intravenous infusion in cycle 1 and as a 7-day continuous intravenous infusion in subsequent cycles every 3 weeks in stable or responding patients. Results Forty patients were enrolled and treated (14 patients in phase I and 26 patients in phase II). Dose-limiting reactions in phase I included hypotension and fever, and the MTD for phase II dosing was established at 3 mg/kg/d. Two (8%) of 26 assessable patients achieved a partial response. Other evidence of antitumor activity included ≥ 50% reduction in splenomegaly (seven of 17 patients; 41%), complete disappearance of hepatomegaly (two of seven patients; 29%), ≥ 50% reduction of lymphadenopathy (seven of 22 patients; 32%), and ≥ 50% reduction in circulating lymphocyte counts (11 of 22 patients; 50%). Adverse events included transient hypotension, fever, fatigue, night sweats, diarrhea, nausea, vomiting, hypokalemia, and cough. Plasma concentrations of oblimersen (parent drug) and its major metabolites were variable. Renal clearance represented only a small portion of total parent drug clearance. Conclusion Dosing with oblimersen sodium in patients with CLL is limited by development of a cytokine release syndrome that is characterized by fever, hypotension, and back pain. Oblimersen sodium has modest single-agent activity in heavily pretreated patients with advanced CLL, and further evaluation of its activity in combination with cytotoxic drugs is warranted.

scholarly journals Phase I and Pharmacokinetic Study of Paclitaxel by 24-Hour Intravenous Infusion

1994 ◽  
Vol 85 (10) ◽  
pp. 1057-1062 ◽  
Author(s):  
Tomohide Tamura ◽  
Yasutsuna Sasaki ◽  
Kenji Eguchi ◽  
Tetsu Shinkai ◽  
Yuichiro Ohe ◽  
...  
Keyword(s):  
Phase I ◽  
Pharmacokinetic Study ◽  
Intravenous Infusion

Phase I and Pharmacokinetic Study of Lapatinib and Docetaxel in Patients With Advanced Cancer

2008 ◽  
Vol 26 (18) ◽  
pp. 3051-3056 ◽  
Author(s):  
Patricia M. LoRusso ◽  
Suzanne F. Jones ◽  
Kevin M. Koch ◽  
Nikita Arya ◽  
Ronald A. Fleming ◽  
...  
Keyword(s):  
Phase I ◽  
Advanced Cancer ◽  
Pharmacokinetic Study

A phase I clinical and pharmacokinetic study of the multi-drug resistance protein-1 (MRP-1) inhibitor sulindac, in combination with epirubicin in patients with advanced cancer

2006 ◽  
Vol 59 (1) ◽  
pp. 79-87 ◽  
Author(s):  
R. O’Connor ◽  
M. O’Leary ◽  
J. Ballot ◽  
C. D. Collins ◽  
P. Kinsella ◽  
...  
Keyword(s):  
Drug Resistance ◽  
Phase I ◽  
Advanced Cancer ◽  
Pharmacokinetic Study ◽  
Multi Drug Resistance ◽  
Resistance Protein

A Phase I Trial of Gemcitabine Administered as a 96-h Continuous Intravenous Infusion in Patients with Advanced Carcinoma and Lymphoma

2006 ◽  
Vol 23 (3) ◽  
pp. 369-376 ◽  
Author(s):  
Lakshmi Rajdev ◽  
Gary Goldberg ◽  
Una Hopkins ◽  
Joseph A. Sparano
Keyword(s):  
Phase I ◽  
Intravenous Infusion ◽  
Phase I Trial ◽  
Continuous Intravenous Infusion ◽  
Advanced Carcinoma

Phase I trial of concurrent intraperitoneal and continuous intravenous infusion of fluorouracil in patients with refractory cancer.

1988 ◽  
Vol 6 (1) ◽  
pp. 158-162 ◽  
Author(s):  
B Reichman ◽  
M Markman ◽  
T Hakes ◽  
N Kemeny ◽  
D Kelsen ◽  
...  
Keyword(s):  
Phase I ◽  
Intravenous Infusion ◽  
Phase I Study ◽  
Clinical Utility ◽  
Phase I Trial ◽  
Drug Exposure ◽  
Continuous Intravenous Infusion ◽  
Future Studies ◽  
Systemic Drug Exposure ◽  
Systemic Drug

In an effort to maximize both local-regional and systemic drug exposure to tumor in the peritoneal cavity, a phase I study was conducted that examined the simultaneous daily intraperitoneal (IP) and continuous intravenous infusion (CVI) of fluorouracil (5-FU) to 32 patients with refractory cancer. IP 5-FU administered at 1,000 mg/d with concurrent 5-FU by CVI at 1,000 mg/m2/d for four consecutive days was well tolerated. One patient with a primary gastrointestinal (GI) malignancy with minimal volume disease experienced a surgically defined complete remission. In theory, this regimen may demonstrate clinical utility as an adjuvant treatment of certain GI malignancies. Future studies are planned in this clinical setting.

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